The Affinity Fusion Oxygenator with Integrated Arterial Filter and… — Class II medical device recall Z-0531-2015
Terminated recall by Medtronic Perfusion Systems, reported 2014-12-17, distributed in CA, FL. Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems w
| Recall number | Z-0531-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2014-10-31 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-08-11 |
| Distributed | CA, FL |
| Countries outside the US | CH, CZ |
| Lot numbers | 12981001, 13011880 |
| Serial numbers | 8110138055, 8110138056, 8110138061, 8110138096, 8110139306, 8110139330, 8110139856, 8110140819, 8110140824, 8110140985, 8110141045, 8110141082, 8110141083, 8110141114, 8110141119, 8110141127, 8110141128, 8110141138, 8110141142, 8110141153, 8110141155, 8110141162, 8110141167, 8110141168, 8110141182 and 58 more |
Product
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging.
Reason for recall
Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. UPDATED: Recall was updated to incorporate three additional lots affected.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0531-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.