Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console — Class I medical device recall Z-1313-2021
Ongoing recall by Medtronic Perfusion Systems, reported 2021-04-07, distributed nationwide. An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit ele
| Recall number | Z-1313-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2021-03-03 |
| Classified | 2021-03-26 |
| Reported by FDA | 2021-04-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CN, CO, EC, ES, GB, GT, HR, IL, IN, IT, JP, KR, MA, MX, NZ, TH, TW, VN |
| UPC / GTIN / UDI-DI | 00613994258236, 00613994450326, 00613994450463, 00613994526052, 00643169201033, 00643169201651, 00643169315822, 00763000135447, 00763000159412, 00763000236526, 00885074539386 |
| Serial numbers | 560B100094, 560B100127, 560B100191, 560B100212, 560B100244, 560B100257, 560B100274, 560B100283, 560B100369, 560B100376, 560B100418, 560B100439, 560B100472, 560B100482, 560B100495, 560B100496, 560B100690, 560B100783, 560B100806, 560B100820, 560B100871, 560B100896, 560B100901, 560B101062, 560B101187 and 366 more |
| Model numbers | 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1 |
Product
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
Reason for recall
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.
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-1313-2021. 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.