Bio-Medicus Life Support™ LS96218-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000615444), received between Mar 7, 2024 and Apr 17, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS LIFE SUPPORT CANNULA HAD NORMAL WIRE (INQUIRE) THAT COULD ONLY BE INSERTED THROUGH THE INTENDED OPENING IN THE CANNULA UNDER HIGH PRESSURE, SUGGESTING THAT THE LUMEN IN THE DILATOR OF THE CANNULA WAS TOO SMALL. THE WIRE WAS PUSHED 10 CM INTO THE CANNULA BUT COULD NOT BE INSERTED FURTHER AND WAS ALMOST UNABLE TO BE REMOVED FROM THE CANNULA. IT WAS NOTED THAT THE WIRE DID NOT FIT THROUGH THE CANNULA, ALTHOUGH IT WAS ABLE TO FIT THROUGH A SMALLER MEDTRONIC 19FR. CANNULA WITHOUT ANY PROBLEMS. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856053 ↗
• MalfunctionNov 12, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE CUSTOMER OBSERVED CLOT FORMATION AT THE TIP UPON WITHDRAWING THE CANNULA FROM THE PATIENT. THE ISSUE OCCURRED AT THE END OF A TWO DAY EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) RUN. 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 20662560 ↗
• MalfunctionMar 7, 2024Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THERE WAS DAMAGE/CRACK TO THE CONNECTOR END OF THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS DAMAGED COMING OUT OF THE PACKAGING. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854108 ↗