Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
FDA Recall Z-1313-2021 · Posted None
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Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWA
Date Initiated2021-03-03
Product Quantity387 devices (93 US)
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.
Firm Action
In the United States (US), beginning 03-Mar-2021, a written Urgent Medical Device Correction letter was mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification.
Root Cause
Component change control
Distribution Pattern
Worldwide distribution. US Nationwide including Puerto Rico, Brazil, Brunei Darussalam, Canada, China, Colombia, Croatia, Ecuador, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Korea, Mexico, Morocco, New Zealand, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, and Viet Nam
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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