Medtronic Recalls Affinity Fusion Oxygenators Due to Plastic Flash Defect
Medtronic is voluntarily recalling specific lots of Affinity Fusion Oxygenators because of an out-of-specification condition involving additional plastic in the arterial sampling port.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a manufacturing defect (plastic flash) in a medical device. The source text does not report any illnesses, injuries, or deaths, and the agency classification is Class II, which aligns with a moderate severity rating for a defect without reported harm.
Plain-English summary
Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance Biosurface. These devices are distributed as stand-alone units, as combination units with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. The recall covers 5,609 units distributed in the United States and internationally.
The recall is due to an identified out-of-specification condition where additional plastic (flash) is present in the arterial sampling port adjacent to the arterial outlet port of the oxygenator. These devices are intended for use in extracorporeal perfusion circuits to oxygenate blood and remove carbon dioxide during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The affected products were distributed nationwide in the United States and in several countries including Canada, Germany, Italy, and the United Kingdom. Specific lot numbers and product codes are listed in the official recall documentation. Healthcare providers and facilities should check their inventory against the provided lot numbers and stop using any affected units.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Inc
Distribution
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