Bio-Medicus Life Support™ LS96555-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000615512), received between Jun 28, 2024 and Apr 25, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionApr 25, 2025Crack; Crack

  IT WAS REPORTED THAT DURING THE USE OF THE BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER OBSERVED CRAZING ON THE CONNECTION END OF THE CANNULA. THE CATHETER WAS STILL USED FOR VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906918 ↗
• MalfunctionJan 16, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) RETRIEVAL PROCEDURE, AFTER CANNULATING THE RIGHT FEMORAL VEIN, THE BIO-MEDICUS LIFE SUPPORT CANNULA'S CONNECTOR WAS FOUND TO BE CRACKED AND DEEMED UNSAFE TO USE. THE CLINICAL TEAM NOTED THAT THE CANNULA "DIDN'T CLICK LIKE THE OTHER ONE." IT WAS ALSO REPORTED THAT THE HAEMOSTASIS CAP WAS NOT USED DURING THE ASSEMBLY OF THE CANNULA. THE INVESTIGATION INTO POTENTIAL DAMAGE BY THE CLINICAL TEAM DURING INSERTION WAS INCONCLUSIVE, AND IT WAS SUGGESTED THAT THE TRANSLUCENT HAEMOSTASIS CAP MIGHT HAVE BEEN DISCARDED IN ERROR PRIOR TO ASSEMBLING THE INTRODUCER INTO THE CANNULA. THE CUSTOMER EXPRESSED CONCERN THAT THE TRANSLUCENT HAEMOSTASIS CAP'S COLOR MATCHED THE PACKAGING, POTENTIALLY LEADING TO OVERSIGHT. A NEW CANNULA WAS PLACED INTO THE PATIENT WITHOUT HARM. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21166158 ↗
• MalfunctionJun 28, 2024Crack; Air/Gas in Device; Crack; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THERE WAS A CRACK IN THE CONNECTOR. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THECANNULA BODY CONNECTOR. THE CUSTOMER INSERTED THE DEVICE BUT THEY CONTINUED TO HAVE AIR WHEN THEY WERE ATTEMPTING TO MAKE A WET CONNECTION. THEY DISCOVERED THE CRACK BEFORE GOING ON PUMP. 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 19631338 ↗