Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1313-2021 — Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.

U.S. FDA — Device Enforcement · United States · 2021-03-03 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1313-2021
Date of alert
2021-03-03
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medtronic Perfusion Systems
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00885074539386
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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