Medtronic Affinity Arterial Filter Recalled for Excess Plastic Flash
Medtronic is recalling 24 units of Affinity 38um Arterial Filters due to excess plastic flash above the outlet 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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing defect (excess plastic flash) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic Perfusion Systems is recalling 24 units of the Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351. The recall is limited to units with UDI 20643169858835 and Lot Number 13316512. These products were distributed in California.
The recall was initiated because Medtronic identified an out-of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port. This manufacturing defect is the specific reason for the recall action.
Healthcare facilities and consumers who have these specific units should stop using them and contact Medtronic Perfusion Systems for further instructions on return or replacement.
The recalled product
- Product
- Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 20643169858835
- Lot Numbers: 13316512
Distribution
Distributed in 1 state:
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