Recall Z-1313-2021 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
| Date | Mar 3, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component change control |
| 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. |
| Quantity | 387 devices (93 US) |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131964 | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE Medtronic, Inc., Jul 24, 2013 |