Medtronic Perfusion Systems
70 recalls on record · Latest: Nov 26, 2025
FDA Devices Moderate Nov 26, 2025
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
FDA Devices Moderate Nov 26, 2025
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
FDA Devices Moderate Nov 19, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
FDA Devices Critical Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
FDA Devices Critical Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
FDA Devices Critical Mar 19, 2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. …
FDA Devices Moderate Jan 29, 2025
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
FDA Devices Moderate Jan 29, 2025
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
FDA Devices Moderate Sep 18, 2024
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
FDA Devices Moderate Jul 31, 2024
TourniKwik Tourniquet Set (CFN 79012)
FDA Devices Moderate May 22, 2024
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
FDA Devices Moderate May 22, 2024
Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 300…
FDA Devices Moderate May 22, 2024
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Mod…
FDA Devices Moderate May 22, 2024
Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number …
FDA Devices Moderate May 22, 2024
Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Press…
FDA Devices Moderate May 22, 2024
Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
FDA Devices Moderate May 22, 2024
Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. So…
FDA Devices Moderate May 22, 2024
Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
FDA Devices Moderate May 22, 2024
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 Number 79009
FDA Devices Moderate May 22, 2024
Medtronic Clearview Blower/Mister, Model Number 22120
FDA Devices Moderate Mar 27, 2024
Medtronic DLP Vessel Cannula, Model Number REF 30000
FDA Devices Moderate Feb 8, 2023
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in …
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Card…
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
FDA Devices Moderate Feb 8, 2023
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in …
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
FDA Devices Moderate Jun 1, 2022
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed i…
FDA Devices Moderate Jan 19, 2022
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model B…
FDA Devices Moderate Dec 1, 2021
Cardioblate CryoFlex Surgical Ablation Console
FDA Devices Moderate Oct 13, 2021
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
FDA Devices Moderate Sep 29, 2021
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
FDA Devices Moderate Sep 29, 2021
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
FDA Devices Moderate Jun 23, 2021
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021