Bio-Medicus Life Support™ LS96550-017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000615482), received between Jan 27, 2026 and May 14, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 16, 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.

• MalfunctionMay 14, 2026Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CATHETER , THE CUSTOMER REPORTED A CRACK ON THE CATHETER CONNECTOR. THE CRACK WAS DESCRIBED AS THE LENGTH OF THE CONNECTOR AND THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171347 ↗
• InjuryJan 27, 2026Crack; Material Deformation

  IT WAS REPORTED THAT AFTER A PATIENT WAS PLACED ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) IN THE INTENSIVE CARE UNIT (ICU), A BIO-MEDICUS LIFE SUPPORT CATHETER AND INTRODUCER WAS INSERTED AND A BROKEN DEFECT WAS OBSERVED IN THE MOST PROXIMAL PART OF THE HARD PLASTIC CONNECTOR TO THE TUBING. THE CANNULA WAS NOT CHANGED DUE TO THE PATIENT¿S CIRCUMSTANCES, AND CONNECTING THE TUBING DID NOT CAUSE ANY PROBLEMS AS THE CONNECTOR WAS SECURED WITH A CABLE TIE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE CANNULA WAS DELIVERED IN A BACK PACK AS THEY HAD TO CANNULATE IN ANOTHER HOSPITAL. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE CUSTOMER CANNULATED BY PLACING THE WHITE INTRODUCER INSIDE WITHOUT APPLYING ANY SPECIAL FORCE. WHEN THEY WERE ABOUT TO CONNECT THE TUBING, THEY NOTICED A CLEAR BREAK IN THE MOST PROXIMAL PART OF THE CANNULA, WHICH APPEARED WHITISH. THE BREAK DID NOT REACH THE END. SINCE THERE WAS A MARGIN THAT WAS NOT BROKEN, THEY DECIDED TO CONNECT THE TUBING AND PROCEED WITH ECMO, AND THEN A MO

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188188 ↗