| 2026-06-24 |
Class II
|
Ongoing |
Z-2811-2026 |
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number … |
— |
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac… |
| 2026-06-24 |
Class II
|
Ongoing |
Z-2810-2026 |
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model… |
— |
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac… |
| 2026-06-24 |
Class II
|
Ongoing |
Z-2809-2026 |
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial retu… |
— |
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac… |
| 2026-06-24 |
Class II
|
Ongoing |
Z-2808-2026 |
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial retu… |
— |
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac… |
| 2026-06-24 |
Class II
|
Ongoing |
Z-2807-2026 |
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return… |
— |
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac… |
| 2026-06-24 |
Class II
|
Ongoing |
Z-2806-2026 |
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return… |
— |
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac… |
| 2026-04-21 |
Class II
|
Ongoing |
Z-2222-2026 |
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular cat… |
— |
Certain lots of product have the potential for a sterile barrier breach. |
| 2026-04-21 |
Class II
|
Ongoing |
Z-2221-2026 |
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular cat… |
— |
Certain lots of product have the potential for a sterile barrier breach. |
| 2026-04-21 |
Class II
|
Ongoing |
Z-2220-2026 |
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular ca… |
— |
Certain lots of product have the potential for a sterile barrier breach. |
| 2026-04-21 |
Class II
|
Ongoing |
Z-2219-2026 |
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular cat… |
— |
Certain lots of product have the potential for a sterile barrier breach. |
| 2026-04-21 |
Class II
|
Ongoing |
Z-2218-2026 |
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular cat… |
— |
Certain lots of product have the potential for a sterile barrier breach. |
| 2026-04-21 |
Class II
|
Ongoing |
Z-2217-2026 |
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular cat… |
— |
Certain lots of product have the potential for a sterile barrier breach. |
| 2026-04-21 |
Class II
|
Ongoing |
Z-2216-2026 |
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular ca… |
— |
Certain lots of product have the potential for a sterile barrier breach. |
| 2026-04-21 |
Class II
|
Ongoing |
Z-2215-2026 |
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular c… |
— |
Certain lots of product have the potential for a sterile barrier breach. |
| 2026-04-21 |
Class II
|
Ongoing |
Z-2214-2026 |
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular… |
— |
Certain lots of product have the potential for a sterile barrier breach. |
| 2026-01-13 |
Class II
|
Ongoing |
Z-1473-2026 |
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 |
— |
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the botto… |
| 2025-10-20 |
Class II
|
Ongoing |
Z-0539-2026 |
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 |
— |
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. |
| 2025-10-03 |
Class II
|
Ongoing |
Z-0509-2026 |
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo |
— |
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the to… |
| 2025-09-12 |
Class II
|
Ongoing |
Z-0487-2026 |
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B |
— |
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. |
| 2025-08-06 |
Class I
|
Ongoing |
Z-2482-2025 |
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115 |
— |
The catheters may not retain their shape. |
| 2025-08-06 |
Class I
|
Ongoing |
Z-2481-2025 |
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 |
— |
The catheters may not retain their shape. |
| 2025-08-06 |
Class I
|
Ongoing |
Z-2480-2025 |
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 |
— |
The catheters may not retain their shape. |
| 2025-02-05 |
Class I
|
Ongoing |
Z-1306-2025 |
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 … |
— |
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. … |
| 2024-12-12 |
Class II
|
Ongoing |
Z-0986-2025 |
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) |
— |
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. |
| 2024-12-12 |
Class II
|
Ongoing |
Z-0985-2025 |
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) |
— |
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. |
| 2024-12-12 |
Class II
|
Ongoing |
Z-0984-2025 |
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr) |
— |
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. |
| 2024-10-03 |
Class II
|
Ongoing |
Z-0289-2025 |
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery |
— |
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal |
| 2024-07-09 |
Class II
|
Ongoing |
Z-3128-2024 |
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 |
— |
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Can… |
| 2024-05-16 |
Class II
|
Ongoing |
Z-2423-2024 |
TourniKwik Tourniquet Set (CFN 79012) |
— |
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1805-2024 |
Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr.… |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1804-2024 |
Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tu… |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1803-2024 |
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.2… |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1802-2024 |
Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in),… |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1801-2024 |
Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,… |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1800-2024 |
Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009… |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1799-2024 |
Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula … |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1798-2024 |
Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourn… |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1797-2024 |
Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent C… |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1796-2024 |
Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1795-2024 |
Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1794-2024 |
Medtronic Clearview Blower/Mister, Model Number 22120 |
— |
Potential for unsealed sterile packing. |
| 2024-03-19 |
Class II
|
Ongoing |
Z-1793-2024 |
Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) D… |
— |
Potential for unsealed sterile packing. |
| 2024-02-07 |
Class II
|
Ongoing |
Z-1316-2024 |
Medtronic DLP Vessel Cannula, Model Number REF 30000 |
— |
Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above. |
| 2022-12-12 |
Class II
|
Ongoing |
Z-1028-2023 |
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Bio… |
— |
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator e… |
| 2022-12-12 |
Class II
|
Ongoing |
Z-1027-2023 |
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Bio… |
— |
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator e… |
| 2022-12-12 |
Class II
|
Ongoing |
Z-1026-2023 |
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Car… |
— |
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator e… |
| 2022-12-12 |
Class II
|
Ongoing |
Z-1025-2023 |
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Car… |
— |
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator e… |
| 2022-12-12 |
Class II
|
Ongoing |
Z-1024-2023 |
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE … |
— |
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator e… |
| 2022-12-12 |
Class II
|
Ongoing |
Z-1023-2023 |
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Car… |
— |
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator e… |
| 2022-04-20 |
Class II
|
Ongoing |
Z-1131-2022 |
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plas… |
— |
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. |
| 2021-10-12 |
Class II
|
Ongoing |
Z-0491-2022 |
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM … |
— |
Product is labeled as non-pyrogenic but endotoxin testing was not performed. |
| 2021-09-27 |
Class II
|
Ongoing |
Z-0273-2022 |
Cardioblate CryoFlex Surgical Ablation Console |
— |
There is potential for intermittent electrical connectivity between the console and probe. |
| 2021-09-13 |
Class II
|
Ongoing |
Z-0003-2022 |
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Veno… |
— |
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers. |
| 2021-08-24 |
Class II
|
Ongoing |
Z-2505-2021 |
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only |
— |
Potential for a wire protrusion through the left heart vent catheter tip |
| 2021-08-24 |
Class II
|
Ongoing |
Z-2504-2021 |
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only |
— |
Potential for a wire protrusion through the left heart vent catheter tip |
| 2021-04-29 |
Class II
|
Terminated |
Z-1895-2021 |
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1894-2021 |
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1893-2021 |
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1892-2021 |
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1891-2021 |
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1890-2021 |
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1889-2021 |
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1888-2021 |
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1887-2021 |
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1886-2021 |
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1885-2021 |
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1884-2021 |
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1883-2021 |
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System, |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1882-2021 |
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1881-2021 |
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1880-2021 |
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1879-2021 |
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1878-2021 |
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1877-2021 |
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1876-2021 |
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1875-2021 |
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1874-2021 |
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1873-2021 |
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1872-2021 |
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-04-29 |
Class II
|
Terminated |
Z-1871-2021 |
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx. |
— |
Specific lots may have been manufactured with insufficient or incomplete welds. |
| 2021-03-03 |
Class I
|
Ongoing |
Z-1313-2021 |
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1… |
— |
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1199-2021 |
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Bala… |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1198-2021 |
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reserv… |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1197-2021 |
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous … |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1196-2021 |
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance … |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1195-2021 |
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (C… |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1194-2021 |
Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reserv… |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1193-2021 |
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiot… |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1192-2021 |
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) wit… |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1191-2021 |
Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENAT… |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |
| 2021-02-04 |
Class I
|
Terminated |
Z-1190-2021 |
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BB… |
— |
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu… |