Medtronic Perfusion Systems recalls
38 recalls in our records from 2014 to 2026: 38 FDA medical devices.
Recalls with full detail pages
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Medtronic Perfusion Systems medical device recall: DLP Left Heart Vent Catheter Malleable body and vented connector
The catheters may not retain their shape.
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Medtronic Perfusion Systems medical device recall: Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR…
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential…
Earlier and other recalls
These link to the official agency notice.
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Medtronic Perfusion Systems medical device recall: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR Official notice ↗
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration…
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Medtronic Perfusion Systems medical device recall: Medtronic DLP One-Piece Pediatric Arterial Cannula Official notice ↗
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
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Medtronic Perfusion Systems medical device recall: Octopus Evolution Tissue Stabilizer Official notice ↗
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom…
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Medtronic Perfusion Systems medical device recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR Official notice ↗
Certain lots of product have the potential for a sterile barrier breach.
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Medtronic Perfusion Systems medical device recall: Octopus Nuvo Tissue Stabilizer Official notice ↗
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the…
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Medtronic Perfusion Systems medical device recall: Medtronic HR-ACT Official notice ↗
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
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Medtronic Perfusion Systems medical device recall: MC3 VitalFlow Console Official notice ↗
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch…
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Medtronic Perfusion Systems medical device recall: Affinity NT Oxygenator Official notice ↗
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
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Medtronic Perfusion Systems medical device recall: DLP Pediatric One-Piece Arterial Cannulae Official notice ↗
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
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Medtronic Perfusion Systems medical device recall: Medtronic DLP Aortic Root Cannula with Flow-Guard Official notice ↗
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
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Medtronic Perfusion Systems medical device recall: Medtronic DLP Single Stage Venous Cannulae with right angle metal tip Official notice ↗
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae -…
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Medtronic Perfusion Systems medical device recall: TourniKwik Tourniquet Set Official notice ↗
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
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Medtronic Perfusion Systems medical device recall: Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip… Official notice ↗
Potential for unsealed sterile packing.
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Medtronic Perfusion Systems medical device recall: Medtronic DLP Vessel Cannula Official notice ↗
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 above.
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Medtronic Perfusion Systems medical device recall: Affinity Fusion Oxygenator with Integrated Arterial Filter and… Official notice ↗
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either…
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Medtronic Perfusion Systems medical device recall: Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System Official notice ↗
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
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Medtronic Perfusion Systems medical device recall: Medtronic Custom Perfusion kits Official notice ↗
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
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Medtronic Perfusion Systems medical device recall: Cardioblate CryoFlex Surgical Ablation Console Official notice ↗
There is potential for intermittent electrical connectivity between the console and probe.
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Medtronic Perfusion Systems medical device recall: Medtronic Bio-Medicus Insertion Kits Official notice ↗
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
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Medtronic Perfusion Systems medical device recall: DLP Left Heart Vent Catheters Official notice ↗
Potential for a wire protrusion through the left heart vent catheter tip
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Medtronic Perfusion Systems medical device recall: Medtronic HY10Z48R2 Official notice ↗
Specific lots may have been manufactured with insufficient or incomplete welds.
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Medtronic Perfusion Systems medical device recall: Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console Official notice ↗
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues…
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Medtronic Perfusion Systems medical device recall: Medtronic Affinity Pixie Hollow Fiber Oxygenator and… Official notice ↗
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute…
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Medtronic Perfusion Systems medical device recall: Extra corporeal circuit with bio-active surface Official notice ↗
Affected products failed a sterilization test.
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Medtronic Perfusion Systems medical device recall: Medtronic Affinity Official notice ↗
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
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Medtronic Perfusion Systems medical device recall: Reservoir "Y" Adapter Official notice ↗
Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when…
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Medtronic Perfusion Systems medical device recall: BIO CAL(R) Temperature Controller Official notice ↗
Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be…
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Medtronic Perfusion Systems medical device recall: Medtronic AFFINITY NT Official notice ↗
Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone…
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Medtronic Perfusion Systems medical device recall: Medtronic Custom Perfusion Systems Official notice ↗
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
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Medtronic Perfusion Systems medical device recall: DLP Extension Line Adapters 20 in length Used to extend cardioplegia… Official notice ↗
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
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Medtronic Perfusion Systems medical device recall: Medtronic Custom Perfusion Tubing Pack Official notice ↗
Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by…
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Medtronic Perfusion Systems medical device recall: Medtronic Perfusion Tubing Packs Official notice ↗
This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and…
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Medtronic Perfusion Systems medical device recall: Medivators Hemocor Hph700 Official notice ↗
Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been…
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Medtronic Perfusion Systems medical device recall: Medtronic EOPA Arterial Cannula Official notice ↗
EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.
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Medtronic Perfusion Systems medical device recall: Medtronic DLP Femoral Arterial Cannula Official notice ↗
Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to…
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Medtronic Perfusion Systems medical device recall: The Affinity Fusion Oxygenator with Integrated Arterial Filter and… Official notice ↗
Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.