Bio-Medicus Life Support™ LS96555-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000615505), received between Apr 22, 2024 and Feb 11, 2025 — 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 18, 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.

• MalfunctionFeb 11, 2025Crack; Crack

  IT WAS REPORTED THAT AFTER UNPACKING THE BIO-MEDICUS LIFE SUPPORT CANNULA, THERE WAS AN OBVIOUS CRACK ON THE PROXIMAL END OF THE CANNULA, WHICH MADE IT UNUSABLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353005 ↗
• MalfunctionMay 14, 2024Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT WHEN LS ARTERIOVENOUS CANNULA LS96555-021 WAS BEING USED IN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PATIENT, IT WAS FOUND THAT THERE WERE CRACKS AT THE TAIL OF THE CANNULA, WHICH AFFECTED THE TREATMENT OF ECMO PATIENT. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307499 ↗
• MalfunctionMay 13, 2024Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THIS DEVICE WAS USED IN ECMO PATIENT TREATMENT, AND CRACKS WERE FOUND AT THE TAIL END OF THE CANNULA. SEE ATTACHED PHOTO. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299327 ↗
• MalfunctionApr 22, 2024Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A LS96555-021 BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED A CRACK IN THE HUB OF THE CANNULA. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THERE IS NO HEMOSTASIS CAP WITH THIS CANNULA MODEL. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19150961 ↗