Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console Recalled by Medtronic Perfusion Systems Due to An electrical component within the system controller module...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Perfusion Systems directly.
Affected Products
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
Quantity: 387 devices (93 US)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Perfusion Systems
Medtronic Perfusion Systems has 96 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report