Bio-Medicus Life Support™ LS96360-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000615604), received between Nov 27, 2025 and Dec 2, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathDec 2, 2025Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CATHETER AND INTRODUCER, IT WAS REPORTED THAT WHILE A PATIENT WAS BEING TREATED WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), WHILE AWAITING POSSIBLE TRANSPLANT OR VENTRICULAR ASSIST DEVICE (VAD) PLACEMENT. DURING MOVEMENT FOR COMPUTED TOMOGRAPHY IMAGING (CT), THE DEVICE USED TO CANNULATE THE NECK BECAME DISLODGED, RESULTING IN AIR ENTERING THE VENOUS LINE AND BLEEDING. AN UNPLANNED TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE BLOOD LOSS. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED BUT WAS UNSUCCESSFUL, AND THE PATIENT DIED. ADDITIONALLY, THE CUSTOMER STATED THAT THE PROCEDURE CAUSED OR CONTRIBUTED TO THE DEATH. THE MEDTRONIC DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

  Patient problems: Air Embolism; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23693445 ↗
• MalfunctionNov 27, 2025Crack; Crack

  IT WAS REPORTED THAT A CRACK WAS IDENTIFIED ON THE PLASTIC PART OF THE CONNECTOR AT THE OPENING OF THE BIO-MEDICUS LIFE SUPPORT CATHETER AND INTRODUCER PRIOR TO USE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665813 ↗