Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
Reported: April 7, 2021 Initiated: March 3, 2021 #Z-1313-2021
Product Description
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.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 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
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.. Recalled by Medtronic Perfusion Systems. Units affected: 387 devices (93 US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 7, 2021. Severity: Critical. Recall number: Z-1313-2021.
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