Bio-Medicus Life Support™ LS96218-017Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000615420), received between Mar 30, 2023 and Sep 9, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Mechanical Problem

  Medtronic received information that during use of a Bio-Medicus Life Support Catheter, it was reported that there was difficulty separating the needle from the body of the cannula. No noticeable damage was observed on the cannula. The device was replaced to complete the case. There was no adverse patient effect associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50688924 ↗
• MalfunctionOct 15, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THERE WAS A CRACK AT THE SIDE HOLE OF THE CANNULA. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449687 ↗
• MalfunctionDec 6, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THAT THEY IDENTIFIED SMALL CRACKS IN THE COUPLING PIECE. THE CUSTOMER NOTICED THAT THE CRACKS APPEARED IMMEDIATELY WHEN INSERTING THE DEVICE. THEY APPEARED WHEN THE CUSTOMER PRESSED THE INTRODUCER INTO THE DEVICE. THERE WAS A PROBLEM WITH THE CANNULATION ACCORDING TO ROUTINE, HOWEVER, THE CUSTOMER NOTICED THAT THE CRACKS APPEARED IN CONNECTION WITH THE DILATOR BEING PUSHED IN. THE DEVICE WAS NOT EXPOSED TO HEAT OR COLD BEFORE INSERTION. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CRACKED PORTION IS AT THE TOP OF THE CONNECTING PART OF THE DEVICE. THE CANNULA WAS USED FOR AN EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273342 ↗
• MalfunctionNov 30, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THAT THERE WAS A SMALL CRACK IDENTIFIED IN THE COUPLING PIECE AND THEY SUSPECTED THERE WAS A CRACK AT THE TOP OF THE CONNECTOR. THE CUSTOMER STATED THERE WAS NO LEAK AND THE PATIENT WAS NOT HARMED. THE CRACK WAS DISCOVERED A DAY AFTER ADMISSION AND APPEARED LIKE A SMALL WHITE LINE. THE DURATION OF THE TREATMENT WITH THE DEFECTIVE DEVICE WAS THREE DAYS. THE CUSTOMER STATED THERE WAS NO PROBLEM INSERTING THIS CANNULA. THERE WAS NO HARM OR BLOOD LOSS RELATED TO THE CANNULA. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE AS THERE WAS NO LEAK OBSERVED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT, HOWEVER THE PATIENT IS NOW DECEASED AND THE CUSTOMER STATED THAT IT WAS NOT IN ANY WAY RELATED TO THE CANNULA. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE CANNULA WAS BEING USED FOR AN EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236062 ↗
• MalfunctionJun 12, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THE DEVICE HAD A DAMAGED CONNECTOR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE WAS SEEN TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105472 ↗
• MalfunctionMay 9, 2023Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THAT SMALL CRACKS WERE OBSERVED IN THE COUPLING PIECE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WASN'T ANY LEAK FROM THE CANNULA, OR FROM THE CONNECTION BETWEEN A CANNULA AND A CONNECTOR. THERE WAS NO PATIENT BLOOD LOSS. NO TRANSFUSION WAS REQUIRED. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS DEVICE WAS BEING USED FOR AN ECMO PROCEDURE. THERE WAS NO INJURY RELATED TO THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895119 ↗
• MalfunctionApr 25, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THAT UPON OPENING THE PACKAGE A CRACK WAS OBSERVED IN THE COUPLING PIECE, THERE WAS NO LEAK. THE DEVICE WAS USED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WERE NO SUTURES NEAR THE DAMAGED PART. JUST A SAFETY STRAP. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS USED FOR ECMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805643 ↗
• MalfunctionMar 30, 2023Crack; Fluid/Blood Leak; Air/Gas in Device; Crack; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE INSERTION OF THE CANNULA WAS EASY BUT THE LUER LOCK DID NOT LOOK 100% SAFE. IT WAS REPORTED THAT THERE WAS A POSSIBILITY OF SUCKING AIR INTO THE CIRCUIT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES. THE CUSTOMER STATED THAT AIR WAS OBSERVED IN THE CIRCUIT. IT WAS STATED THAT INFORMATION ON WHETHER THE CANNULA WAS USED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OR CARDIOPULMONARY BYPASS (CPB) WAS UNKNOWN. IT WAS STATED THAT THE CONNECTION WAS NOT LEAKING, IT WAS THE LUERLOCK ON THE CANNULAE THAT SUCKED AIR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS PLACED IN THE V. J. RIGHT WITHOUT ANY PROBLEMS. THE LUER LOCK WAS NOT TIGHT (LEAKY) AND AIR WAS DRAWN INTO THE CANNULA. IT WAS REPORTED THAT POTENTIALLY, THIS COULD HAVE LEAD TO AIR EMBOLISM AND BLEEDING (AS A RESULT OF EXCHANGE). IT WAS REPORTED THAT THE LEAK WAS LIKE THE CAP THAT CLOSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644573 ↗