Recall archive
37 recalls · page 1 of 2
Reported Aug 5, 2026
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia,…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2026
Octopus Evolution Tissue Stabilizer, Model TS2000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2026
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Certain lots of product have the potential for a sterile barrier breach.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 4, 2026
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached…
FDA (openFDA device enforcement)
Reported Nov 26, 2025
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand — The catheters may not retain their shape.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand — Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use -…
FDA (openFDA device enforcement)
Reported Jan 29, 2025
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage…
FDA (openFDA device enforcement)
Reported Jul 31, 2024
TourniKwik Tourniquet Set (CFN 79012)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
FDA (openFDA device enforcement)
Reported May 22, 2024
Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Potential for unsealed sterile packing.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Medtronic DLP Vessel Cannula, Model Number REF 30000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed…
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Product is labeled as non-pyrogenic but endotoxin testing was not performed.
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Cardioblate CryoFlex Surgical Ablation Console
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — There is potential for intermittent electrical connectivity between the console and probe.
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Potential for a wire protrusion through the left heart vent catheter tip
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Specific lots may have been manufactured with insufficient or incomplete welds.
24 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to…
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may…
9 more products in this recall
FDA (openFDA device enforcement)
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