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medtronic perfusion systems

19 recalls on record

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Medtronic Perfusion Systems — Octopus Evolution AS Tissue Stabilizer, Model TS2500

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

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Medtronic Perfusion Systems — Octopus Evolution Tissue Stabilizer, Model TS2000

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

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Medtronic Perfusion Systems — Octopus 4 Tissue Stabilizer, Model 29400

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

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Medtronic Perfusion Systems — Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

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Medtronic Perfusion Systems — Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

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Medtronic Perfusion Systems — Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

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Medtronic Perfusion Systems — Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

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Medtronic Perfusion Systems — Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

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Medtronic Perfusion Systems — Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

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Medtronic Perfusion Systems — Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

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Medtronic Perfusion Systems — Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

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Medtronic Perfusion Systems — Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

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Medtronic Perfusion Systems — Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

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 canister, and the long tube was attached to the top, contrary to the intended design.

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Medtronic Perfusion Systems — Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

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 — MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

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 screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

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Medtronic Perfusion Systems — Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

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 — DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

The catheters may not retain their shape.

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Medtronic Perfusion Systems — DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

The catheters may not retain their shape.

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Medtronic Perfusion Systems — DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

The catheters may not retain their shape.