Brand

Medtronic Perfusion Systems Recalls

70 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Medtronic Perfusion Systems.

70Total Recalls
10Critical
978,827Units Affected
Jan 13, 2026Most Recent
All Recalls

Every Medtronic Perfusion Systems Recall

Sorted by most recent. Click any recall for full details.

70 recalls
High RiskFDA
Medtronic Perfusion Systems
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Medical Devices·2 affected·Jan 13, 2026
High RiskFDA
Medtronic Perfusion Systems
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Medical Devices·3,850 affected·Oct 20, 2025
High RiskFDA
Medtronic Perfusion Systems
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Medical Devices·167 affected·Oct 3, 2025
High RiskFDA
Medtronic Perfusion Systems
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Respiratory Devices·26 affected·Sep 12, 2025
CriticalFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Cardiac Devices·41,200 affected·Aug 6, 2025
CriticalFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Cardiac Devices·25,261 affected·Aug 6, 2025
CriticalFDA
Medtronic Perfusion Systems
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA...
Medical Devices·316,205 affected·Feb 5, 2025
High RiskFDA
Medtronic Perfusion Systems
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Medical Devices·745 affected·Dec 12, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Medical Devices·290 affected·Jul 9, 2024
High RiskFDA
Medtronic Perfusion Systems
TourniKwik Tourniquet Set (CFN 79012)
Medical Devices·636 affected·May 16, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
Medical Devices·1,624 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Mode...
Medical Devices·5,719 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronar...
Medical Devices·1,410 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., M...
Cardiac Devices·13,954 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m ...
Medical Devices·6,290 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
Medical Devices·250 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft wi...
Medical Devices·13,198 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
Medical Devices·7,935 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model ...
Medical Devices·1,760 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Clearview Blower/Mister, Model Number 22120
Medical Devices·500 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic DLP Vessel Cannula, Model Number REF 30000
Medical Devices·4,343 affected·Feb 7, 2024
High RiskFDA
Medtronic Perfusion Systems
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB81...
Respiratory Devices·40,498 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Respiratory Devices·2,937 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. ...
Respiratory Devices·90,220 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
Respiratory Devices·4,462 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB81...
Respiratory Devices·63,278 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
Respiratory Devices·1,340 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray...
Surgical Devices·1,236 affected·Apr 20, 2022
High RiskFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FIL...
Medical Devices·6,653 affected·Oct 12, 2021
High RiskFDA
Medtronic Perfusion Systems
Cardioblate CryoFlex Surgical Ablation Console
Surgical Devices·7 affected·Sep 27, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit,...
Medical Devices·168 affected·Sep 13, 2021
High RiskFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Cardiac Devices·48,672 affected·Aug 24, 2021
High RiskFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Cardiac Devices·51,494 affected·Aug 24, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Medical Devices·5 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Medical Devices·25 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Medical Devices·12 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·15 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Medical Devices·2 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Medical Devices·10 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Medical Devices·3 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Medical Devices·61 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Medical Devices·16 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·6 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Medical Devices·10 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Medical Devices·15 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Medical Devices·6 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·1 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Medical Devices·8 affected·Apr 29, 2021