Bio-Medicus Life Support™ LS96360-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000615574), received between Aug 6, 2024 and Aug 5, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical 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 18, 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 5, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, WHILE THE CANNULA WAS INSERTED INTO THE FEMORAL VEIN OF THE PATIENT THE CUSTOMER COULD NOT REMOVE THE DILATOR FROM THE SHEATH. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22712517 ↗
• MalfunctionDec 10, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, UPON OPENING THE PRODUCT THE CUSTOMER EXPERIENCED DIFFICULTY WITH THE INTRODUCER, WHICH COULD NOT BE REMOVED FROM THE CATHETER BODY DUE TO IT BEING STICKY/HIGH FRICTION AT A SPECIFIC POINT. THE CANNULA BODY WAS WETTED WITH SALINE PRIOR TO INTRODUCING THE WHITE INTRODUCER, FOLLOWING CUSTOMER PROTOCOL. THE INTRODUCER COULD ONLY BE RETRACTED BY APPROXIMATELY 7-10 CM BEFORE STICKING. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890276 ↗
• MalfunctionAug 6, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE CANNULA WAS UNPACKED, RINSED AND ASSEMBLED. AFTER CANNULATION AND PLACEMENT THE CUSTOMER COULD NOT GET THE INTRODUCER OUT. THE CUSTOMER USED QUITE SOME FORCE, BUT IT WOULD NOT BUDGE. SO THEY REPLACED THE GUIDEWIRE AND REPLACED WITH HLS CANNULA. AFTER REMOVAL THEY TESTED THE CANNULA AND IS SEEMED FINE, TIP WAS NOT BENT. WHAT THEY DID NOTICE, IS THAT WHEN THE CANNULA IS SLIGHTLY BENT, THE INTRODUCER IS STUCK. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE LOOKS PERFECT. THE CUSTOMER USED THE SAME INITIAL INSERTION SITE FOR THE REPLACED CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917044 ↗