Bio-Medicus Life Support™ LS96555-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000615529), received between Oct 12, 2023 and Oct 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIOMEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THAT THEY PLACED THE CANNULA THROUGH A TUNNELED INCISION THROUGH THE CHEST INTO THE AORTA IN A STANDARD FASHION. THE CUSTOMER REPORTED THAT THEY WERE UNSUCCESSFUL WHEN THEY TRIED TO REMOVE THE DILATOR. THE DEVICE APPEARED TO BE STUCK. THE CUSTOMER LEFT THE WIRE IN, REMOVED THE CANNULA AND REPLACED IT WITH A NEW DEVICE WHEN TRYING TO REMOVE THE DILATOR. THE CUSTOMER HAD SOME TROUBLE BUT WAS ABLE TO REMOVE THE DILATOR AND PROCEED WITH THE PROCEDURE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER STATED THAT THERE WAS NO NOTICEABLE DAMAGE TO THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919357 ↗