Medtronic Perfusion Systems

Complete recall history across all FDA and CPSC categories — 96 total recalls

Medtronic Perfusion Systems appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (96)

FDA medical device enforcement actions by Medtronic Perfusion Systems. Showing most recent 50.

Date Product Reason Class
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Mode... Certain lots of product have the potential for a sterile barrier breach. Class II
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Mo... Certain lots of product have the potential for a sterile barrier breach. Class II
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II
Jan 13, 2026 Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Produ... During the manufacturing, Medtronic personnel identified an assembly issue wh... Class II
Oct 20, 2025 Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 Medtronic personnel observed trace amounts of dry blood on the external carto... Class II
Oct 3, 2025 MC3 VitalFlow Console, REF 58100; Blood pump of ecmo As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Cons... Class II
Sep 12, 2025 Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardi... Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas tr... Class II
Aug 6, 2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... The catheters may not retain their shape. Class I
Aug 6, 2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... The catheters may not retain their shape. Class I
Aug 6, 2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... The catheters may not retain their shape. Class I
Feb 5, 2025 Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUA... Unexpected loose material in the male luer used in the aortic root cannula ha... Class I
Dec 12, 2024 Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) Incorrect labeling for seven manufactured lots of certain models of Arterial ... Class II
Dec 12, 2024 EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) Incorrect labeling for seven manufactured lots of certain models of Arterial ... Class II
Dec 12, 2024 DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 770... Incorrect labeling for seven manufactured lots of certain models of Arterial ... Class II
Oct 3, 2024 Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in card... There is the potential for a potential sterility breach for three lots of the... Class II
Jul 9, 2024 Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model ... Class II
May 16, 2024 TourniKwik Tourniquet Set (CFN 79012) Incorrect component placed in four manufactured lots of the TourniKwik" Tourn... Class II
Mar 19, 2024 Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Ca... Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial... Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 ... Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Clearview Blower/Mister, Model Number 22120 Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model ... Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip,... Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring ... Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Mode... Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt,... Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model ... Potential for unsealed sterile packing. Class II
Mar 19, 2024 Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Mode... Potential for unsealed sterile packing. Class II
Feb 7, 2024 Medtronic DLP Vessel Cannula, Model Number REF 30000 Medtronic is writing to inform you of incorrect labeling for three manufactur... Class II
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TM... Class II
Dec 12, 2022 Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... An upward trend of complaints in which the Temperature Monitoring Adapter (TM... Class II
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TM... Class II
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TM... Class II
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TM... Class II
Dec 12, 2022 Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... An upward trend of complaints in which the Temperature Monitoring Adapter (TM... Class II
Apr 20, 2022 Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is p... Firm detected an increase in complaints related to fractured jaw tips of the ... Class II
Oct 12, 2021 Medtronic Custom Perfusion kits, with the following product descriptions and ... Product is labeled as non-pyrogenic but endotoxin testing was not performed. Class II
Sep 27, 2021 Cardioblate CryoFlex Surgical Ablation Console There is potential for intermittent electrical connectivity between the conso... Class II
Sep 13, 2021 Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion... There was a label mix-up between two model numbers resulting in the incorrect... Class II
Aug 24, 2021 DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only Potential for a wire protrusion through the left heart vent catheter tip Class II
Aug 24, 2021 DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only Potential for a wire protrusion through the left heart vent catheter tip Class II
Apr 29, 2021 Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, St... Specific lots may have been manufactured with insufficient or incomplete welds. Class II

View all 96 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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