Medtronic Custom Perfusion Systems — Class II medical device recall Z-0535-2018
Terminated recall by Medtronic Perfusion Systems, reported 2018-02-14, distributed in CA, DE, IA. Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow thr
| Recall number | Z-0535-2018 |
|---|---|
| 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 | 2018-01-03 |
| Classified | 2018-02-06 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-10-05 |
| Distributed | CA, DE, IA |
| Countries outside the US | JP |
| Quantity | 2,914 units |
| UPC / GTIN / UDI-DI | 00613994268174, 00643169471986, 00643169510432, 00643169661295, 00643169715097, 00643169735989, 00643169741591, 00643169789517, 00643169845077, 00643169845121, 00643169872127, 00643169906181, 00763000025878, 20613994490760, 20643169876648, 20885074191038 |
| Serial numbers | 209533592, 209759280, 209948919, 210174899, 210377603, 210478517, 210591995, 210731697, 210767149, 210802114, 210838201, 210937492, 210937507, 210937704, 210945613, 210952226, 211011818, 211050766, 211114272, 211210180, 211210404, 211243436, 211320749, 211327621, 211335076 and 81 more |
| Model numbers | 2815R1, 2D25R6, 9M68R, BB4B15R13, BB4B15R14, BB9L72R, BB9L72R1, CB1Z87R11, CB4L56R24, CB4L56R26, CB5S68R3, CB7X82R4, CB7X82R5, HY6Y19R5, HY8M65R2, TL8W39R6 |
Product
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Reason for recall
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
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-0535-2018. 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.