Bio-Medicus Life Support™ LS96218-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000615437), received between Aug 4, 2023 and Jul 9, 2025 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN OBSTRUCTED CANNULA WAS IDENTIFIED WITH THE BIO-MEDICUS LIFE SUPPORT CATHETER AND INTRODUCER DURING USE. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455971 ↗
• MalfunctionJan 17, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE CONNECTOR WAS CRACKED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. IT WAS ALSO REPORTED THAT THE CANNULA WAS NOT CRACKED BEFORE INSERTION, HOWEVER THE HEMOSTASIS CAP WAS MISSED BETWEEN THE CANNULA AND THE INTRODUCER DURING INSERTION. SO, THE INTRODUCER WAS USED FOR INSERTION WITHOUT THE HEMOSTASIS CAP. THE CUSTOMER REPORTED THAT THE CAUSE OF THIS WAS THAT THE HEMOSTASIS CAP IS COMPLETELY TRANSPARENT AND IS NOT ON THE CANNULA BUT ON THE PROTECTIVE PACKAGING AROUND THE INTRODUCER. IT WAS TAKEN AS A PROTECTIVE PACKAGING AND NOT AS A PROTECTION FOR THE CANNULA. THE HEMOSTASIS CAP WAS SUBSEQUENTLY DISCARDED BEFORE INSERTION OF THE CANNULA. THE CUSTOMER ALSO REPORTED THAT ACCORDING TO THEIR EXPERIENCE, THERE IS A DEFICIENCY IN THE PLASTIC (IT IS TOO FRAGILE) EVEN IF THE HEMOSTASIS CAP IS ON, AND ALSO THAT THE COLOR AND/OR PLACEMENT OF THE HEMOSTASIS CAP IN THE PACKAGING IS AN ISSUE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS USED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THERE WAS NO LEAK FROM THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525435 ↗
• MalfunctionJan 10, 2024Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THAT THEY FOUND A DEFECTIVE DEVICE WITH EXTENSIVE CRACKING RIGHT OUT OF THE PACKAGE. THE DEVICE HAD NOT BEEN EXPOSED TO HEAT AND COLDNESS OR ANYTHING THAT COULD EXPLAIN THIS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482566 ↗
• MalfunctionSep 28, 2023Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A 19 FR LIFE SUPPORT BIO-MEDICUS CATHETER, IT WAS REPORTED THAT THE CUSTOMER OB SERVED SMALL CRACKS IN THE COUPLING PIECE. THE DEVICE IS STILL IN USE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CANNULA IS STILL IN THE PATIENT AS THERE IS NO LEAKAGE. THE ISSUE HAS NOT LED TO ANY COMPLICATION OR INJURY. NO CRACKS WERE VISIBLE BEFORE ADMISSION, THE CRACKS WERE DISCOVERED ONE DAY AFTERWARDS. THERE WERE NO PROBLEMS DURING ADMISSION ACCORDING TO THE OPERATIVE REPORT. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE, IT WAS A NORMAL TEMPERATURE, TAKEN DIRECTLY FROM OUR STORAGE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17831973 ↗
• MalfunctionAug 4, 2023Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 19 FR LIFE SUPPORT BIO-MEDICUS CATHETER, IT WAS REPORTED THAT THE PRODUCT WAS KINKED AT THE POINT OF ENTRY/SECUREMENT CAUSING SOME RESTRICTED FLOW. THE USE OF THE DEVICE WAS ASKED BUT UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17457027 ↗