Medtronic Affinity Pixie Hollow Fiber Oxygenator and… — Class I medical device recall Z-1190-2021
Terminated recall by Medtronic Perfusion Systems, reported 2021-03-24, distributed nationwide. Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated
| Recall number | Z-1190-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2021-02-04 |
| Classified | 2021-03-17 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2024-04-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, CL, CN, CO, DE, EG, GB, IQ, IT, JP, KR, LV, NI, PL, PY, QA, RO, VN |
| Quantity | 2,374 units |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00643169089037, 20613994746508 |
| Lot numbers | 13337110, 13337512, 13337675, 13339043, 13339133, 13339290, 13339452, 13339527, 13340766, 13342814, 13344059, 13344325, 13344487, 13344594, 13344819, 13346440, 13346564, 13346733, 13347774, 13347907, 13347974, 13348151, 13348285, 13348521, 13348909, 13348974, 13349141, 13349283, 13349388, 13349517, 13349775, 13352832, 13352983, 13353163, 13353438, 13353541, 13353701, 13353800 |
| Model numbers | BBP241 |
Product
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).
Reason for recall
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
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-1190-2021. 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.