Medtronic Perfusion Systems
Brooklyn Park, MN
This page shows every FDA and USDA recall linked to Medtronic Perfusion Systems. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
121
Total Recalls
2004
First Recall
2026
Most Recent
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Feb 26, 2026
· Device
Open, Classified
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Nov 18, 2025
· Device
Open, Classified
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Nov 14, 2025
· Device
Open, Classified
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product N...
Nov 10, 2025
· Device
Open, Classified
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 121...
Sep 3, 2025
· Device
Open, Classified
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 121...
Sep 3, 2025
· Device
Open, Classified
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 121...
Sep 3, 2025
· Device
Open, Classified
Aortic Root Cannula:
1. DLP Aortic Root Cannula
A. CANNULA 11012 AR FLOWGUARD 12GA, model no
11012
B. CANNULA...
Mar 13, 2025
· Device
Open, Classified
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Jan 17, 2025
· Device
Open, Classified
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Jan 17, 2025
· Device
Open, Classified
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Jan 17, 2025
· Device
Open, Classified
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Nov 4, 2024
· Device
Open, Classified
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Sep 12, 2024
· Device
Open, Classified
TourniKwik Tourniquet Set (CFN 79012)
Jul 23, 2024
· Device
Open, Classified
Medtronic Vessel Cannulae:
a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004;
b) DLP 3 mm Vessel Ca...
May 10, 2024
· Device
Open, Classified
Medtronic Clearview Blower/Mister, Model Number 22120
May 10, 2024
· Device
Open, Classified
Medtronic Cardioplegia Adapters:
a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Numbe...
May 10, 2024
· Device
Open, Classified
Medtronic Tourniquet Sets:
a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004,
b) DLP 7 in (17.8 cm)...
May 10, 2024
· Device
Open, Classified
Medtronic Left Heart Vent Catheters:
a) DLP Intracardiac Sump 20 Fr, Model Number 12012,
b) DLP Left Heart...
May 10, 2024
· Device
Open, Classified
Medtronic Aortic Root Cannulae and Cardioplegia Needles:
a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Numb...
May 10, 2024
· Device
Open, Classified
Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
May 10, 2024
· Device
Open, Classified
Medtronic Venous Cannulae:
a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120,
b) DLP...
May 10, 2024
· Device
Open, Classified
Medtronic Intracoronary Shunts:
a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100;
b) ClearVi...
May 10, 2024
· Device
Open, Classified
Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
May 10, 2024
· Device
Open, Classified
Medtronic Suction Tubes:
a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050,
b) DLP Suct...
May 10, 2024
· Device
Open, Classified
Medtronic Disposable Pressure Display Sets:
a) DLP 114.3 cm (45 in), Model Number 61000;
b) DLP 114.3 cm (4...
May 10, 2024
· Device
Open, Classified
Medtronic Arterial Cannulae packaged as:
a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020...
May 10, 2024
· Device
Open, Classified
Medtronic DLP Vessel Cannula, Model Number REF 30000
Mar 19, 2024
· Device
Open, Classified
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. U...
Jan 27, 2023
· Device
Open, Classified
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. U...
Jan 27, 2023
· Device
Open, Classified
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and B...
Jan 27, 2023
· Device
Open, Classified
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. U...
Jan 27, 2023
· Device
Open, Classified
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and B...
Jan 27, 2023
· Device
Open, Classified
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION...
Jan 27, 2023
· Device
Open, Classified
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a sn...
Apr 20, 2022
· Device
Open, Classified
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers:...
Oct 12, 2021
· Device
Open, Classified
Cardioblate CryoFlex Surgical Ablation Console
Sep 27, 2021
· Device
Open, Classified
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 9...
Sep 13, 2021
· Device
Open, Classified
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Aug 24, 2021
· Device
Open, Classified
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Aug 24, 2021
· Device
Open, Classified
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Apr 29, 2021
· Device
Terminated