Medtronic Bio-Console 560 Blood Pump Console May Stop Pumping Due to Electrical Failure
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63171-medtronic-bio-console-560-blood-pump-console-may-stop-pumping.
Source Summary by GovInfoNow · govinfonow.com/recall/63171-medtronic-bio-console-560-blood-pump-console-may-stop-pumping · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1313-2021
Cite this page
“Medtronic Bio-Console 560 Blood Pump Console May Stop Pumping Due to Electrical Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63171-medtronic-bio-console-560-blood-pump-console-may-stop-pumping. Based on FDA recall #Z-1313-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1313-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Healthcare professionals using these consoles during cardiopulmonary bypass (CPB) procedures are affected. The risk is highest for surgical teams using the recalled models.
How to tell if you have this one
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.
- Brand
Medtronic Perfusion Systems- Product
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1- Category
Medical device
What to do — step by step
Check Model and Serial Numbers
Identify the model number (560BC, 560BC1, 560BCS, or 560BCS1) and serial number from the device label.
Contact Medtronic for Replacement
Reach out to Medtronic directly to arrange for a replacement or repair of the affected console.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1313-2021 (March 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1313-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.