Bio-Console® E560BCS1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994450456), received between May 19, 2023 and Aug 28, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Power Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE CONTROLLER INSTRUMENT, IT WAS REPORTED THAT THERE WAS NO AC POWER. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913832 ↗
• MalfunctionJun 21, 2023Power Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE OF THIS BIO-CONSOLE INSTRUMENT THE SERVICE TECHNICIAN OBSERVED THAT THE FRONT PANEL CHARGE INDICATOR LIGHT WAS FLICKERING AT A HIGH RATE. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171894 ↗
• MalfunctionMay 19, 2023Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS BIO-CONSOLE INSTRUMENT THERE WAS AN AC POWER ISSUE. USE OF INSTRUMENT WAS CONTINUED AND THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE HAND CRANK WAS NOT USED TO MAINTAIN FLOW AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960322 ↗