Bio-Medicus Life Support™ LS96218-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000615413), received between Jul 12, 2024 and Sep 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559965 ↗
• MalfunctionMay 6, 2026Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE DEVICE HAD A BROKEN TIP. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. IT WAS DIFFICULT TO REMOVE AFTER THE RESISTANCE WITH PASSING OVER WIRE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096083 ↗
• MalfunctionJul 16, 2024Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE CUSTOMER DISCOVERED CRACKS AT THE BOTTOM OF THE CANNULAE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19748934 ↗
• MalfunctionJul 12, 2024Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF BIO-MEDICUS LIFE SUPPORT CANNULAE, IT WAS REPORTED THAT THE CUSTOMER DISCOVERED CRACKS AT THE BOTTOM OF THE CANNULAE. THE USE OF THE DEVICES WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728621 ↗