FDA recall record · openFDA
Medtronic Perfusion Systems
37 FDA recalls on record (2024–2026) — 37 device. 37 still ongoing.
4
Class I (most serious)
33
Class II
0
Class III
37
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Potential for unsealed sterile packing. 13
Certain lots of product have the potential for a sterile barrier breach. 9
The catheters may not retain their shape. 3
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. 3
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance 1
Recalls
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 Class I 2025-08-06 Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 Class I 2025-02-05 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115 Class I 2025-08-06 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 Class I 2025-08-06 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular cat Class II 2026-04-21 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular cat Class II 2026-04-21 Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 Class II 2026-01-13 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular ca Class II 2026-04-21 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular Class II 2026-04-21 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular cat Class II 2026-04-21 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular cat Class II 2026-04-21 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular cat Class II 2026-04-21 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular ca Class II 2026-04-21 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular c Class II 2026-04-21 Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B Class II 2025-09-12 Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 Class II 2025-10-20 MC3 VitalFlow Console, REF 58100; Blood pump of ecmo Class II 2025-10-03 Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Class II 2024-03-19 Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Class II 2024-03-19 Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.2 Class II 2024-03-19 Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent C Class II 2024-03-19 Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, Class II 2024-03-19 Medtronic DLP Vessel Cannula, Model Number REF 30000 Class II 2024-02-07 Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 Class II 2024-03-19 Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tu Class II 2024-03-19 Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 Class II 2024-07-09 DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr) Class II 2024-12-12 TourniKwik Tourniquet Set (CFN 79012) Class II 2024-05-16 Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 Class II 2024-03-19 Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourn Class II 2024-03-19 Medtronic Clearview Blower/Mister, Model Number 22120 Class II 2024-03-19 EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) Class II 2024-12-12 Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009 Class II 2024-03-19 Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery Class II 2024-10-03 Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) Class II 2024-12-12 Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) D Class II 2024-03-19 Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Class II 2024-03-19
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.