Affinity Fusion" Oxygenator with Integrated Arterial Filter — Class II medical device recall Z-0826-2017
Terminated recall by Medtronic Inc, reported 2016-12-28, distributed nationwide. Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenator
| Recall number | Z-0826-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc, Minneapolis, MN, United States |
| Recall initiated | 2016-11-16 |
| Classified | 2016-12-19 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, DE, ES, GB, GR, HR, HU, IR, IT, LB, LV, PL, PT, RO |
| UPC / GTIN / UDI-DI | 00643169178168, 00643169178175, 00643169354869, 00643169354883, 00643169430143, 00643169463929, 00643169467873, 00643169471597, 00643169506169, 00643169518131, 00643169534629, 00643169546431, 00643169552852, 00643169572263, 00643169583238, 00643169587106, 00643169591738, 00643169617971, 00643169621473, 00643169631649, 00643169639058, 00643169645424, 00643169648111, 00643169649101, 00643169649767 and 44 more |
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 intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
Reason for recall
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.
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-0826-2017. 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.