Danvers, MA, US · 8 510(k) clearances · 110 PMAs · 80 recalls (45 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DYB | Introducer, Catheter | Class II | Cardiovascular | 5 | 2025-10-08 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | Class II | Cardiovascular | 2 | 2023-02-23 |
| MJN | Catheter, Intravascular Occluding, Temporary | Class II | Cardiovascular | 1 | 2023-06-30 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-06-15 | P140003-S138 | Impella CP with SmartAssist | Special (Immediate Track) | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2026-04-07 | P140003-S137 | Impella 5.5 with Smart Assist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2026-04-01 | P170011-S063 | Impella RP System | Special (Immediate Track) | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2026-02-06 | P170011-S061 | Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System | Real-Time Process | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2026-02-06 | P140003-S135 | Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-12-19 | P170011-S062 | Impella CP with SmartAssist; Impella 5.5 with SmartAssist | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2025-12-19 | P140003-S136 | Impella CP with SmartAssist; Impella 5.5 with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-10-01 | P140003-S131 | Impella 5.5 with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-09-24 | P140003-S130 | Impella CP with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-09-19 | P170011-S060 | Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2025-09-19 | P140003-S129 | Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-09-15 | P170011-S058 | Purge Cassette | Normal 180 Day Track No User Fee | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2025-09-15 | P140003-S126 | Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-08-08 | P140003-S124 | Impella CP with SmartAssist System | 135 Review Track For 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-08-01 | P170011-S056 | Impella RP System; Impella RP with SmartAssist System; Impella RP Flex with SmartAssist System; | Normal 180 Day Track No User Fee | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2025-08-01 | P140003-S123 | Impella 5.5 with SmartAssist System; Impella CP with SmartAssist System; Impella 2.5; Impella 5.0; Impella LD; | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-07-25 | P170011-S059 | Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2025-07-25 | P140003-S128 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-06-23 | P170011-S057 | Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2025-06-23 | P140003-S125 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-06-20 | P140003-S127 | IMPELLA CP with Smart Assist | Special (Immediate Track) | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-02-04 | P140003-S122 | Impella CP with SmartAssist | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2025-01-10 | P170011-S055 | Impella RP with SmartAssist, Impella RP Flex with SmartAssist | Special (Immediate Track) | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2024-12-03 | P140003-S111 | Impella CP with SmartAssist, Impella 5.5 with SmartAssist | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2024-10-29 | P140003-S121 | Impella CP with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2024-10-21 | P140003-S119 | Impella 5.5 with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2024-09-12 | P140003-S118 | Impella CP with SmartAssist, Impella 5.5 with SmartAssist | Special (Immediate Track) | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2024-04-17 | P170011-S053 | Impella RP and Impella RP with SmartAssist | Special (Immediate Track) | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2024-01-05 | P140003-S116 | Impella CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist | Special (Immediate Track) | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2023-12-21 | P170011-S052 | Impella RP, Impella RP with SmartAssist and Impella RP Flex Systems | Special (Immediate Track) | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2023-12-21 | P140003-S117 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems | Special (Immediate Track) | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2023-11-29 | P140003-S115 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist | Special (Immediate Track) | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2023-06-27 | P140003-S112 | Impella CP with SmartAssist | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2023-06-23 | P170011-S050 | Impella RP Flex with SmartAssist | Special (Immediate Track) | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2023-06-14 | P140003-S113 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist | Special (Immediate Track) | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2023-04-27 | P170011-S049 | Impella RP, Impella RP with Smart Assist, Impella $.0/LD | Normal 180 Day Track No User Fee | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2023-04-27 | P140003-S110 | Impella 2.5, Impella CP and CP with SmartAssist | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2023-04-13 | P140003-S109 | Impella CP with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2023-03-31 | P170011-S048 | Impella RP Flex with SmartAssist | Real-Time Process | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2023-03-29 | P140003-S107 | Impella Ventricular Support Systems | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2023-01-06 | P140003-S106 | Impella2.5, ImpellaCP, Impella CP with SmartAssist | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-12-05 | P170011-S047 | Impella RP, Impella RP with SmartAssist | Normal 180 Day Track No User Fee | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-10-28 | P170011-S040 | Impella RP Flex with SmartAssist and Impella RP with SmartAssist | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-10-28 | P170011-S039 | Impella RP Flex with SmartAssist | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-10-28 | P140003-S099 | Impella CP with SmartAssist, Impella 5.5 with SmartAssist | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-10-11 | P170011-S046 | Impella RP and Impella RP with SmartAssist | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-10-06 | P170011-S044 | Impella RP, Impella RP with SmartAssist | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-10-04 | P140003-S094 | Impella 5.5 with SmartAssist | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-09-06 | P140003-S105 | Impella CP with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-08-31 | P170011-S045 | Impella RP, Impella RP with SmartAssist | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-08-31 | P140003-S103 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-08-19 | P170011-S043 | Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist | Normal 180 Day Track No User Fee | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-08-18 | P140003-S102 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-07-08 | P140003-S098 | Impella 2.5, Impella CP, Impella CP with SmartAssist | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-07-08 | P140003-S096 | Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-07-01 | P170011-S042 | Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-07-01 | P140003-S101 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-06-16 | P170011-S041 | Impella RP, Impella RP with Smart Assist | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-06-16 | P140003-S100 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with Smart Assist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-04-19 | P170011-S035 | Impella RP System, Impella RP with SmartAssist System | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-04-19 | P140003-S088 | Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-04-12 | P170011-S038 | Impella RP, Impella RP with SmartAssist | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-04-12 | P140003-S097 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-04-08 | P140003-S093 | Impella 5.5 with SmartAssist | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-04-05 | P140003-S092 | Impella CP with SmartAssist | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-03-16 | P170011-S036 | Impella RP and Impella RP with SmartAssist | Real-Time Process | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-03-16 | P140003-S091 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2022-03-08 | P170011-S037 | Impella RP, Impella RP with SmartAssist | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2022-03-08 | P140003-S095 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-11-22 | P170011-S034 | Impella RP | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2021-11-22 | P140003-S089 | Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-11-22 | P140003-S085 | Impella CP with SmartAssist | 135 Review Track For 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-11-22 | P140003-S084 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-10-15 | P140003-S086 | Impella 5.5 with SmartAssist | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-08-23 | P140003-S087 | Impella 5.5 with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-07-13 | P140003-S083 | Impella Ventricular Support Systems | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-07-13 | P140003-S082 | Impella Left Ventricular Support Systems | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-07-13 | P140003-S081 | Impella Ventricular Support Systems | Normal 180 Day Track No User Fee | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-07-12 | P170011-S033 | Impella RP System | Normal 180 Day Track No User Fee | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2021-07-09 | P170011-S031 | Impella RP System | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2021-07-09 | P140003-S078 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist System | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-06-28 | P170011-S032 | Impella RP System | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2021-06-28 | P170011-S030 | Impella RP with SmartAssist System | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2021-06-28 | P170011-S026 | Impella RP System | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2021-06-28 | P140003-S080 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-06-15 | P170011-S029 | Impella RP System | Normal 180 Day Track No User Fee | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2021-03-12 | P170011-S027 | Impella RP | 135 Review Track For 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2021-03-12 | P140003-S076 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD | 135 Review Track For 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-03-10 | P140003-S074 | Impella 2.5 System, Impella CP System and Impella CP System with SmartAssist System, Impella 5.0 System, Impella LD Syst | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2021-02-17 | P140003-S079 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, and Impella 5.0/LD | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-11-06 | P170011-S028 | Impella RP | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2020-11-06 | P140003-S077 | Impella 2.5, Impella CP, Impelia CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-09-09 | P140003-S075 | Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist. | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-08-04 | P170011-S025 | Impella RP System | Normal 180 Day Track No User Fee | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2020-08-04 | P140003-S072 | Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-07-10 | P170011-S024 | Impella RP System | Real-Time Process | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2020-07-10 | P140003-S073 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, Impella 5.0, and Impella LD Systems | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-06-26 | P140003-S065 | Impella 2.5, CP, and CP with SmartAssist | 135 Review Track For 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-04-17 | P140003-S070 | Automated Impella Controller | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-04-09 | P170011-S023 | Impella RP | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2020-04-09 | P140003-S071 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-04-01 | P170011-S021 | Impella RP System | Real-Time Process | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2020-04-01 | P140003-S068 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD and Impella 5.5 with SmartAssist Systems | Real-Time Process | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-03-30 | P170011-S022 | Impella RP System | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2020-02-28 | P140003-S069 | Impella CP with SmartAssist | 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-02-18 | P140003-S059 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD Systems | 135 Review Track For 30-Day Notice | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-01-30 | P170011-S015 | Automated Impella Controller | Normal 180 Day Track | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2020-01-30 | P140003-S057 | Automated Impella Controller | Normal 180 Day Track | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| 2020-01-24 | P170011-S020 | Impella RP System | 30-Day Notice | PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular |
| 2020-01-22 | P140003-S066 | IMPELLA 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and | Special (Immediate Track) | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-08-12 | Class I | Ongoing | Z-3150-2026 | Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions an… | — | The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. |
| 2026-08-12 | Class I | Ongoing | Z-3149-2026 | Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Contr… | — | The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. |
| 2026-08-12 | Class I | Ongoing | Z-3148-2026 | Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Contr… | — | The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. |
| 2026-06-11 | Class I | Ongoing | Z-2693-2026 | ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-30… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2692-2026 | ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pum… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2691-2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessori… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2690-2026 | ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. h… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2689-2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessori… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2688-2026 | ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-300… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2687-2026 | ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2686-2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Tap… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2685-2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Tap… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2684-2026 | ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer P… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2683-2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2682-2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Cod… | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-06-11 | Class I | Ongoing | Z-2681-2026 | ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 … | — | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing … |
| 2026-05-22 | Class I | Ongoing | Z-2602-2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25… | — | Potential for thrombus formation during prolonged use of the introducer. |
| 2026-05-22 | Class I | Ongoing | Z-2601-2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product … | — | Potential for thrombus formation during prolonged use of the introducer. |
| 2026-05-22 | Class I | Ongoing | Z-2600-2026 | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product C… | — | Potential for thrombus formation during prolonged use of the introducer. |
| 2026-05-22 | Class I | Ongoing | Z-2599-2026 | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product C… | — | Potential for thrombus formation during prolonged use of the introducer. |
| 2026-05-18 | Class I | Ongoing | Z-2457-2026 | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. | — | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulat… |
| 2026-05-14 | Class I | Ongoing | Z-2360-2026 | Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with correspon… | — | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. |
| 2026-04-20 | Class I | Ongoing | Z-2211-2026 | Automated Impella Controller (AIC); Product Code: 0042-0000-US; | — | A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have… |
| 2026-02-18 | Class I | Ongoing | Z-1589-2026 | Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat… | — | Increased risk of purge leaks with Generation 1 purge cassettes. |
| 2026-02-16 | Class I | Ongoing | Z-1591-2026 | Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller… | — | Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (055… |
| 2026-01-27 | Class I | Ongoing | Z-1471-2026 | Impella RP. Product Code: 0046-0011. | — | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| 2026-01-27 | Class I | Ongoing | Z-1470-2026 | Impella RP Flex with SmartAssist. Product Code: 1000323. | — | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| 2026-01-27 | Class I | Ongoing | Z-1469-2026 | Impella RP with SmartAssist. Product Code: 0046-0035. | — | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| 2025-12-04 | Class II | Ongoing | Z-1030-2026 | Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. | — | Device packaged in incorrect outer box carton. |
| 2025-10-01 | Class I | Ongoing | Z-0069-2026 | Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding … | — | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). |
| 2025-09-16 | Class I | Ongoing | Z-0136-2026 | Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect … | — | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. |
| 2025-08-20 | Class I | Ongoing | Z-2568-2025 | Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co… | — | Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump perfo… |
| 2025-06-23 | Class I | Ongoing | Z-2164-2025 | Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Contr… | — | A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected |
| 2024-12-12 | Class I | Ongoing | Z-0830-2025 | Impella RP Flex with SmartAssist; Product Number: 1000323; | — | Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and… |
| 2024-12-12 | Class I | Ongoing | Z-0829-2025 | Impella RP with SmartAssist; Product Number: 0046-0035; | — | Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and… |
| 2024-08-05 | Class II | Ongoing | Z-2971-2024 | Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2970-2024 | Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2969-2024 | Impella CP Smart Assist Set; Product Code: 1000402; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2968-2024 | Impella 5.5 Set AU; Product Code: 1000361; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2967-2024 | ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2966-2024 | Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2965-2024 | Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2964-2024 | Pump 381 Pump Set (US); Product Code: 1000080; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2963-2024 | Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2962-2024 | Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2961-2024 | Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2960-2024 | Impella CP Smart Assist Set APAC; Product Code: 0048-0047; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2959-2024 | Pump 371 14F LT CMR Set; Product Code: 0048-0045; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2958-2024 | Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2957-2024 | Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2956-2024 | Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2955-2024 | Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-08-05 | Class II | Ongoing | Z-2954-2024 | Impella CP Smart Assist Set, EU; Product Code: 0048-0014; | — | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abi… |
| 2024-05-31 | Class I | Ongoing | Z-2319-2024 | Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump | — | Nine (9) Impella CP pumps failed inspection and were inadvertently released. |
| 2023-12-27 | Class II | Ongoing | Z-1074-2024 | Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code… | — | New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may r… |
| 2023-12-27 | Class I | Ongoing | Z-0980-2024 | Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Cod… | — | IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. |
| 2023-12-06 | Class II | Ongoing | Z-0636-2024 | Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote… | — | The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notificati… |
| 2023-11-07 | Class II | Ongoing | Z-0655-2024 | Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of th… | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-11-07 | Class II | Ongoing | Z-0654-2024 | Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for i… | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-11-07 | Class II | Ongoing | Z-0653-2024 | Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Imp… | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-11-07 | Class II | Ongoing | Z-0652-2024 | Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte… | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-11-07 | Class II | Ongoing | Z-0651-2024 | Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the… | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-11-07 | Class II | Ongoing | Z-0650-2024 | Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the… | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-11-07 | Class II | Ongoing | Z-0649-2024 | Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part … | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-11-07 | Class II | Ongoing | Z-0648-2024 | Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Imp… | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-11-07 | Class II | Ongoing | Z-0647-2024 | Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Ca… | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-11-07 | Class II | Ongoing | Z-0646-2024 | Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body… | — | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product ex… |
| 2023-10-10 | Class II | Terminated | Z-0441-2024 | Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1. | — | Pump not detected as connected to controller due to software issue. |
| 2023-10-10 | Class II | Terminated | Z-0440-2024 | Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1. | — | Pump not detected as connected to controller due to software issue. |
| 2023-06-29 | Class I | Ongoing | Z-2281-2023 | Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323 | — | A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous… |
| 2023-06-14 | Class I | Ongoing | Z-2116-2023 | Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080 | — | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) re… |
| 2023-06-14 | Class I | Ongoing | Z-2115-2023 | Impella CP intravascular micro axial blood pump, Product Number 0048-0032 | — | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) re… |
| 2023-06-14 | Class I | Ongoing | Z-2114-2023 | Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100 | — | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) re… |
| 2023-06-14 | Class I | Ongoing | Z-2113-2023 | Impella LD intravascular micro axial blood pump, Product Number 005082 | — | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) re… |
| 2023-06-14 | Class I | Ongoing | Z-2112-2023 | Impella 5.0 intravascular micro axial blood pump, Product Number 005062 | — | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) re… |
| 2023-06-14 | Class I | Ongoing | Z-2111-2023 | Impella 2.5 intravascular micro axial blood pump, Product Number 005042 | — | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) re… |
| 2023-05-26 | Class II | Ongoing | Z-2128-2023 | Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 | — | There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a… |
| 2023-04-17 | Class I | Ongoing | Z-1590-2023 | Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory s… | — | The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. |
| 2021-12-14 | Class I | Terminated | Z-0550-2022 | OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pum… | — | The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on su… |
| 2021-03-01 | Class II | Terminated | Z-1175-2024 | Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular… | — | Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 wh… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-08 | K252766 | 14Fr Low Profile Introducer Kit | DYB | Class II | Cardiovascular |
| 2024-08-06 | K241708 | Abiomed 14Fr Low Profile Introducer Kit | DYB | Class II | Cardiovascular |
| 2023-06-30 | K221294 | preCARDIA Occlusion System | MJN | Class II | Cardiovascular |
| 2023-02-23 | K223161 | OXY-1 System | DTZ | Class II | Cardiovascular |
| 2022-10-13 | K222113 | Abiomed 14Fr Low Profile Introducer Set | DYB | Class II | Cardiovascular |
| 2020-12-07 | K202330 | Impella XR Sheath Set | DYB | Class II | Cardiovascular |
| 2020-10-23 | K200109 | OXY-1 System | DTZ | Class II | Cardiovascular |
| 2020-06-15 | K201116 | Abiomed 23 Fr Sheath | DYB | Class II | Cardiovascular |