Fremont, CA, US · 17 510(k) clearances · 34 PMAs · 15 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QJP | — | — | — | 9 | 2026-07-01 |
| HCG | — | — | — | 4 | 2025-12-11 |
| POL | — | — | — | 3 | 2023-03-29 |
| MOF | — | — | — | 1 | 2020-09-25 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-06-26 | P170024-S026 | Surpass Evolve; Surpass Elite FDS | 30-Day Notice | OUT | — | — |
| 2025-08-20 | P170024-S024 | Surpass Streamline Flow Diverter | 30-Day Notice | OUT | — | — |
| 2025-06-24 | P180031-S006 | Neuroform Atlas® Stent System | Normal 180 Day Track No User Fee | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2025-05-30 | P170024-S023 | Surpass Streamline Flow Diverter | 30-Day Notice | OUT | — | — |
| 2025-05-09 | P180031-S011 | Neuroform Atlas Stent System | 30-Day Notice | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2025-02-12 | P170024-S022 | Surpass Elite Flow Diverter System | Real-Time Process | OUT | — | — |
| 2024-12-09 | P180031-S010 | Neuroform Atlas Stent System | 30-Day Notice | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2024-11-18 | P180031-S009 | Neuroform Atlas Stent System | 30-Day Notice | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2024-10-16 | P170024-S018 | Surpass Elite Flow Diverter System | Real-Time Process | OUT | — | — |
| 2024-10-06 | P170024-S021 | Surpass Evolve Flow Diverter Systems, Surpass Elite Flow Diverter Systems | 30-Day Notice | OUT | — | — |
| 2024-09-20 | P180031-S008 | Neuroform Atlas® Stent System | 30-Day Notice | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2024-09-20 | P180031-S007 | Neuroform Atlas® Stent System | 30-Day Notice | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2024-09-05 | P170024-S020 | Surpass Evolve and Elite Flow Diverter | 30-Day Notice | OUT | — | — |
| 2024-08-05 | P170024-S019 | Surpass Evolve Flow Diverter Systems | 30-Day Notice | OUT | — | — |
| 2024-06-26 | P170024-S017 | Surpass Elite Flow Diverter System | 30-Day Notice | OUT | — | — |
| 2024-05-30 | P170024-S016 | Surpass Evolve Flow Diverter System | 30-Day Notice | OUT | — | — |
| 2024-05-18 | P170024-S012 | Surpass Elite Flow Diverter System | Normal 180 Day Track | OUT | — | — |
| 2024-03-12 | P170024-S014 | Surpass Evolve Flow Diverter System | 135 Review Track For 30-Day Notice | OUT | — | — |
| 2023-12-05 | P170024-S015 | Surpass Evolve Flow Diverter Systems | 30-Day Notice | OUT | — | — |
| 2023-09-12 | P170024-S013 | Surpass Evolve Flow Diverter Stent System | Real-Time Process | OUT | — | — |
| 2022-11-15 | P180031-S005 | Neuroform Atlas® Stent System | 30-Day Notice | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2022-08-05 | P170024-S010 | Surpass Streamline Flow Diverter | Normal 180 Day Track No User Fee | OUT | — | — |
| 2022-02-07 | P180031-S004 | Neuroform Atlas® Stent System | 30-Day Notice | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2021-11-30 | P170024-S011 | Surpass Evolve Flow Diverter System | 30-Day Notice | OUT | — | — |
| 2021-07-12 | P170024-S009 | Surpass Evolve Flow Diverter System | 30-Day Notice | OUT | — | — |
| 2021-06-09 | P170024-S008 | Surpass Streamline Flow Diverter System, Surpass Evolve Flow Diverter System | 30-Day Notice | OUT | — | — |
| 2021-04-27 | P170024-S007 | Surpass Evolve Flow Diverter System, Surpass Streamline Flow Diverter System | 30-Day Notice | OUT | — | — |
| 2020-12-15 | P170024-S006 | Surpass Streamline Flow Diverter | 30-Day Notice | OUT | — | — |
| 2020-11-17 | P170024-S005 | Surpass Evolve Flow Diverter System | 30-Day Notice | OUT | — | — |
| 2020-09-14 | P170024-S004 | Surpass Streamline Flow Diverter | Real-Time Process | OUT | — | — |
| 2020-08-18 | P180031-S003 | Neuroform Atlas Stent System | 30-Day Notice | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2020-07-30 | P180031-S001 | Neuroform Atlas® Stent System | Panel Track | QCA | Intracranial Coil-Assist Stent | Unknown |
| 2020-05-20 | P170024-S003 | Surpass Evolve Flow Diverter System | Normal 180 Day Track | OUT | — | — |
| 2020-01-18 | P180031-S002 | Neuroform Atlas® Stent System | Normal 180 Day Track No User Fee | QCA | Intracranial Coil-Assist Stent | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-08-30 | Class II | Ongoing | Z-0021-2025 | The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) … | — | Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), dif… |
| 2024-04-23 | Class II | Ongoing | Z-1909-2024 | Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNC… | — | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI… |
| 2024-04-23 | Class II | Ongoing | Z-1908-2024 | DAC 044 115cm, Catalog: 90760 | — | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI… |
| 2024-04-23 | Class II | Ongoing | Z-1907-2024 | FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 | — | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI… |
| 2024-04-23 | Class II | Ongoing | Z-1906-2024 | Trevo Trak 21 Microcatheter, Catalog: 90338 | — | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI… |
| 2024-04-23 | Class II | Ongoing | Z-1905-2024 | Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+… | — | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI… |
| 2024-04-23 | Class II | Ongoing | Z-1904-2024 | Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238 | — | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI… |
| 2024-04-23 | Class II | Ongoing | Z-1903-2024 | Trevo ProVue, Catalog: 90184 | — | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI… |
| 2024-04-23 | Class II | Ongoing | Z-1902-2024 | Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retr… | — | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI… |
| 2024-04-18 | Class II | Ongoing | Z-1941-2024 | The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shap… | — | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backl… |
| 2024-04-18 | Class II | Ongoing | Z-1940-2024 | The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and p… | — | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backl… |
| 2024-04-18 | Class II | Ongoing | Z-1939-2024 | The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro … | — | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backl… |
| 2024-04-03 | Class II | Ongoing | Z-1740-2024 | The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the d… | — | Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lo… |
| 2022-06-03 | Class II | Ongoing | Z-1386-2022 | Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK… | — | Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. |
| 2020-09-21 | Class I | Terminated | Z-0114-2021 | Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: … | — | Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever c… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-01 | K261889 | Trevo Trak 21 Microcatheter | QJP | — | — |
| 2026-02-11 | K253032 | AXS Lift Intracranial Base Catheter | QJP | — | — |
| 2025-12-11 | K252694 | Target Detachable Coil | HCG | — | — |
| 2025-10-17 | K251832 | InZone IST Detachment System; IZDS Connecting Cable | HCG | — | — |
| 2025-03-21 | K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | QJP | — | — |
| 2025-02-18 | K243593 | AXS Lift Intracranial Base Catheter | QJP | — | — |
| 2024-12-19 | K241768 | Broadway 8 Catheter | QJP | — | — |
| 2024-12-19 | K241637 | Echo Intracranial Base Catheter | QJP | — | — |
| 2023-03-29 | K223305 | Trevo NXT ProVue Retriever | POL | — | — |
| 2022-12-14 | K222533 | Target Tetra Detachable Coils | HCG | — | — |
| 2021-11-26 | K211594 | Trevo Trak 21 Microcatheter | QJP | — | — |
| 2021-11-16 | K212455 | InZone Detachment System | HCG | — | — |
| 2021-08-27 | K210502 | Trevo NXT ProVue Retriever | POL | — | — |
| 2021-08-27 | K202752 | AXS Vecta 46 Intermediate Catheter | QJP | — | — |
| 2020-12-29 | K203219 | Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever | POL | — | — |
| 2020-09-25 | K202522 | Synchro SELECT Guidewire | MOF | — | — |
| 2020-02-27 | K200206 | AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter | QJP | — | — |