Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extra...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDAMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
- FDAMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter2026-04-21
- FDAMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter2026-04-21
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →