Medtronic recalls Bio-Console 560 blood pumping consoles with specific model numbers and serials. The system may stop pumping, show blank interface, or produce burning odor due to electrical component failure.
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.
Medtronic is recalling certain Bio-Console 560 blood pumping consoles that may stop working unexpectedly, show a blank screen, or emit a burning smell. This could lead to the blood pump failing during critical surgery.
An electrical component in the system controller may fail, causing the blood pump to stop working. This could lead to the pump shutting down during surgery, resulting in a lack of blood circulation for the patient.
Healthcare professionals using these consoles during cardiopulmonary bypass (CPB) procedures are affected. The risk is highest for surgical teams using the recalled models.
Check the model numbers: 560BC, 560BC1, 560BCS, 560BCS1. Also verify the serial numbers and GTINs listed in the recall notice. These consoles are used in heart surgery procedures.
Identify the model number (560BC, 560BC1, 560BCS, or 560BCS1) and serial number from the device label.
Reach out to Medtronic directly to arrange for a replacement or repair of the affected console.
The recall includes Bio-Console 560 models with numbers 560BC, 560BC1, 560BCS, and 560BCS1, along with specific serial numbers and GTINs listed in the notice.
The device may stop pumping, show a blank user interface, or produce a burning smell and smoke during use.
Yes, if the pump stops working during surgery, it could lead to a lack of blood circulation for the patient.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1313-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1313-2021 from Medtronic Perfusion Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
