Medtronic Perfusion Systems recalls
Every recall we track for Medtronic Perfusion Systems — 109 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 6 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Medtronic Perfusion Systems fell by more than half in 2025 (7, down from 20 in 2024). 6% rated “stop using now”.
All FDA recall records for Medtronic Perfusion Systems since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 3 | 2 | 5 |
| 2018 | 1 | 2 | 2 | 2 | 7 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 16 | 14 | 11 | 41 |
| 2022 | 0 | 6 | 1 | 0 | 7 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 18 | 2 | 20 |
| 2025 | 0 | 1 | 5 | 1 | 7 |
| 2026 (to date) | 5 | 1 | 11 | 4 | 21 |
Most common reasons for Medtronic Perfusion Systems recalls
What to do if you have a recalled Medtronic Perfusion Systems product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Medtronic Perfusion Systems recalls
32 shown- Stop using nowMedical device
Medtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial
Medtronic recalls EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR for possible pinhole leaks during cardiopulmonary bypass that could cause bleeding, vessel damage, or organ failure.
Medtronic Perfusion SystemsJun 24, 2026 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Medtronic recalls adult cannula kits with trace blood material that may cause loose foreign objects. Affected units include specific product numbers and lot numbers. Contact Medtronic for details.
MedtronicMay 25, 2026 - Lower riskMedical device
Medtronic Perfusion Systems recalls Octopus Evolution AS Tissue Stabilizer, Model TS2500
Medtronic recalls Octopus Evolution AS Tissue Stabilizer Model TS2500 with incorrect tube assembly. Affected units have specific serial numbers and UDI-DI codes. Consumers should contact Medtronic for details.
Medtronic Perfusion SystemsMay 12, 2026 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular
Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94725) due to potential sterile barrier breach. Affected units may pose infection risks during medical procedures.
MedtronicApr 21, 2026 - Lower riskMedical device
Medtronic Perfusion Systems recalls Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Medtronic recalls Octopus Nuvo Tissue Stabilizer (Product TSMICS1) due to incorrect tubing assembly during manufacturing, which may cause improper function.
Medtronic Perfusion SystemsJan 13, 2026 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Medtronic recalls HR-ACT cartridges with dry blood on labels. This could lead to contamination during use. Affected units include specific lot numbers. Contact Medtronic for details.
Medtr: a short, human brand name for headings (e.g. "Trsmima")Oct 20, 2025 - Lower riskMedical device
Medtronic Perfusion Systems recalls MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Medtronic recalls VitalFlow Consoles with E70 error code that causes temporary touch screen unresponsiveness. This issue may occur during normal operation but does not affect pump function.
MedtronicOct 3, 2025 - Lower riskMedical device
Medtronic Perfusion Systems recalls Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic recalls Affinity NT Oxygenators with decreased CO2 gas transfer rates that may not meet performance requirements. Affected units have specific product numbers and serial codes.
Medtronic Perfusion SystemsSep 12, 2025 - Lower riskMedical device
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Medtronic recalls specific left heart vent catheters that may not retain their shape. Affected models include SUCTION 12110 LV VENT 10FR with serial numbers from 2023120708 to 2024090768. Contact Medtronic for details.
MedtronicAug 6, 2025 - Use cautionMedical device
Medtronic Perfusion Systems recalls Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR
Recalled Medtronic Perfusion Systems Aortic Root Cannula models 11012 AR, 11014 AR, and variants due to potential loose material causing stroke if not identified before use.
Medtronic Perfusion SystemsFeb 5, 2025 - Lower riskMedical device
Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Medtronic recalls specific pediatric arterial cannula models due to incorrect labeling in certain lots. Affected units may have labeling errors that could lead to improper use during medical procedures.
Medtronic Perfusion SystemsDec 12, 2024 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Medtronic recalls DLP Aortic Root Cannula with Flow-Guard (REF 11012) due to potential sterility breach from misaligned seal in specific lots. Affected units sold for cardiopulmonary bypass surgery.
Medtronic Perfusion SystemsOct 3, 2024 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Medtronic recalls DLP Single Stage Venous Cannulae (REF 67312) due to manufacturing error where straight tip models were incorrectly labeled as right angle metal tip. Affected units have specific lot numbers and GTIN.
Medtronic Perfusion SystemsJul 9, 2024 - UnratedMedical device
Medtronic Perfusion Systems recalls TourniKwik Tourniquet Set (CFN 79012)
Medtronic recalls TourniKwik Tourniquet Set (CFN 79012) due to incorrect component in some lots. Affected units have specific serial numbers. Consumers should contact Medtronic for details.
Medtronic Perfusion SystemsMay 16, 2024 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in),
Medtronic recalls disposable pressure display sets with model numbers 61000 and 62000 due to potential unsealed sterile packing. Affected units include specific lot numbers and GTINs from March 2023.
MedtronicMar 19, 2024 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic DLP Vessel Cannula, Model Number REF 30000
Medtronic recalls DLP Vessel Cannula model REF 30000 with incorrect labeling for specific lots. This may cause confusion in medical use. Affected units include lot numbers 2023020890, 202305C126, and 2023020889.
MedtronicFeb 7, 2024 - Use cautionMedical device
Medtronic Perfusion Systems recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance
Recall of Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance due to Temperature Monitoring Adapter coming loose during setup or disassembly, potentially causing complications during cardiopulmonary bypass procedures.
Medtronic Perfusion SystemsDec 12, 2022 - Lower riskMedical device
Medtronic Perfusion Systems recalls Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on
Medtronic recalls Cardioblate Gemini-S surgical ablation systems due to reported fractured jaw tips. Affected units include specific model numbers and lot numbers. Consumers should contact Medtronic for details.
Medtronic Perfusion SystemsApr 20, 2022 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM
Medtronic recalls 48 specific perfusion kit models due to endotoxin testing not being conducted, which may pose a risk of infection in medical use.
Medtronic Perfusion SystemsOct 12, 2021 - Lower riskMedical device
Medtronic Perfusion Systems recalls Cardioblate CryoFlex Surgical Ablation Console
Medtronic recalls Cardioblate CryoFlex Surgical Ablation Consoles with potential intermittent electrical connectivity between console and probe. Affected units have specific serial numbers and models.
Medtronic Perfusion SystemsSep 27, 2021 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551,
Medtronic recalls two pediatric insertion kit models due to label mix-up causing incorrect guidewire in kits. Affected kits have specific serial numbers and GTINs.
Medtronic Perfusion SystemsSep 13, 2021 - Use cautionMedical device
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Medtronic recalls DLP Left Heart Vent Catheters (model 12118) with potential wire protrusion through the catheter tip. Affected units have specific lot numbers and expiration dates from 09/30/2020 to 05/19/2024.
Medtronic Perfusion SystemsAug 24, 2021 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic recalls specific lots of Custom Perfusion Systems due to potential insufficient welds that could cause leaks. Affected units have GTIN 00763000156879 and lot number 221679870.
Medtronic Perfusion SystemsApr 29, 2021 - Use cautionMedical device
Medtronic Perfusion Systems recalls Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1,
Medtronic recalls Bio-Console 560 blood pumping consoles with specific model numbers and serials. The system may stop pumping, show blank interface, or produce burning odor due to electrical component failure.
Medtronic Perfusion SystemsMar 3, 2021 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie
Medtronic recalls infant tubingsets due to potential bacterial endotoxin levels that could cause acute inflammatory responses in patients. Affected units include specific model and lot numbers.
Medtronic Perfusion SystemsFeb 4, 2021 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Medtronic recalls Affinity 38um Arterial Filters with excess plastic (flash) that could cause blockages. Affected units have specific catalog and lot numbers.
Medtronic Perfusion SystemsNov 14, 2019 - Use cautionMedical device
Medtronic Perfusion Systems recalls SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use
Medtronic recalls suction and anticoagulation assemblies (BTC93/BTC98) with Y-connectors that may tear or crack, causing leaks and blood loss during use. Affected units have specific serial numbers.
Medtronic Perfusion SystemsNov 27, 2018 - Lower riskMedical device
Medtronic Perfusion Systems recalls Extra corporeal circuit with bio-active surface.
Medtronic Perfusion Systems recalls extra corporeal circuits with bio-active surfaces that failed sterilization tests. Affected units may pose infection risks.
Medtr: a short, human brand name for headings (e.g. "Trsmima")Aug 8, 2018 - Stop using nowMedical device
Medtronic Perfusion Systems recalls BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer
Medtronic recalls BIO CAL(R) Temperature Controllers (Models 370 and 370I) due to inability to develop a safe cleaning protocol. Affected units must be discontinued and disposed of immediately.
Medtronic Perfusion SystemsFeb 8, 2018 - UnratedMedical device
Medtronic Perfusion Systems recalls Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous
Medtronic recalls AFFINITY NT Cardiotomy/Venous Reservoirs with Filter due to possible sterile barrier breach in the pouch. This could lead to infection during surgery. Affected units include all lots of the 540 model.
MedtronicJan 16, 2018 - Lower riskMedical device
Medtronic Perfusion Systems recalls Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB)
Medtronic recalls custom perfusion tubing packs with Terumo OPS valves that may lack flow during cardiopulmonary bypass surgery. Affected units have specific lot/serial numbers listed in the recall.
MedtronicJan 3, 2018 - Lower riskMedical device
Medtronic Perfusion Systems recalls DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit
Medtronic Perfusion Systems recalls DLP Pressure Disposable Pressure Display Sets with small pinholes in sterile pouch packaging. Seven product models affected. No remedy specified.
Medtronic Perfusion SystemsJun 22, 2017
Medtronic Perfusion Systems recall questions
How many recalls has Medtronic Perfusion Systems had?
109 recalls from Medtronic Perfusion Systems are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Medtronic Perfusion Systems recall?
Medtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial, dated Jun 24, 2026. Every Medtronic Perfusion Systems recall is listed on this page, newest first.
Why are Medtronic Perfusion Systems products recalled?
The most common reasons on record: Specific lots may have been manufactured with insufficient or incomplete welds. (25); 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).
What should I do if I have a recalled Medtronic Perfusion Systems product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Medtronic Perfusion Systems recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.