Bio-Medicus Life Support™ LS96555-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000615499), received between Aug 31, 2023 and Jul 31, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Crack; Crack

  IT WAS REPORTED THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA DURING THE PRE-OPERATIVE FILLING, BEFORE OPENING THE PACKAGE AND PREPARING TO USE THE CANNULA, A CRACK WAS OBSERVED ON THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673443 ↗
• MalfunctionJul 21, 2025Crack; Crack

  IT WAS REPORTED THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, WHEN THE PACKAGE WAS OPENED A CRACK WAS OBSERVED ON THE CONNECTOR. THE DEVICE WAS REPLACED. SEE ATTACHED PHOTOS/VIDEOS. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS FOR ECMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553117 ↗
• MalfunctionJul 4, 2025Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CATHETER AND INTRODUCER, IT WAS REPORTED THAT DURING THE PRIMING PROCESS, IT WAS OBSERVED THAT THE TUBING WAS RUPTURED/CRACKED. THE DEVICE WAS BEING USED TO IMPROVE ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME). THE CUSTOMER PERFORMED AN EXTRACORPOREAL MEMBRANE OXYGENATION PROCEDURE ON THE PATIENT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402533 ↗
• MalfunctionJul 2, 2024Fracture; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available; Fracture; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS BIO-MEDICUS LIFE SUPPORT CANNULA HAD FRACTURED AT THE CONNECTION SITE FROM THE EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULA (3/8¿ CONNECTOR) TO THE CIRCUIT. THE CUSTOMER STATED THAT THE CONNECTOR WALL OF THIS CANNULA APPEARS VERY THIN. THE FRACTURE WAS NOTICED IN TIME. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653774 ↗
• MalfunctionJun 11, 2024Break; Crack; Material Deformation; Break; Crack; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING, THE CONE WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT 'CONE' REFERS TO THE TIP OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509124 ↗
• MalfunctionOct 9, 2023Crack; Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device; Crack; Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT WHEN CONNECTING THE EXTRACORPOREAL LIFE SUPPORT, THE OPERATOR NOTICED MICRO AIR BUBBLES AND THAT THE CANNULA CONNECTOR WAS CRACKED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894188 ↗
• MalfunctionAug 31, 2023Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THE CATHETER WAS BROKEN. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660529 ↗