Bio-Medicus Life Support™ LS96360-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000615581), received between Jun 2, 2023 and Aug 31, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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.

• MalfunctionAug 31, 2026Mechanical Problem

  PLI 10 and PLI 20: Medtronic received information that during use of a Bio-Medicus life support cannula, it got stuck in the valve case and customer experienced insertion/removal issues. The device was replaced to complete the procedure. Patient outcome and status were unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533640 ↗
• MalfunctionAug 31, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533635 ↗
• MalfunctionJul 22, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE INSERTION OF THE BIO-MEDICUS LIFE SUPPORT CATHETER AND INTRODUCER, AFTER THE PRODUCT WAS PLACED IN THE INTENDED POSITION, THE INTRODUCER COULD NOT BE WITHDRAWN, WHICH WAS UNUSUAL FOR THIS PRODUCT AND NOT PREVIOUSLY EXPERIENCED BY THE HOSPITAL. THE SURGICAL PROCEDURE WAS PERFORMED FOLLOWING THE USUAL PROTOCOL. NO PRE-USE TESTING WAS PERFORMED DUE TO THE EMERGENCY OF THE CASE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THE ALTERNATIVE MODEL FUNCTIONED NORMALLY WITHOUT ANY COMPLICATIONS. IT WAS UNKNOWN IF THERE WAS ANY COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563742 ↗
• MalfunctionNov 22, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT UPON CANNULATING THE PATIENT VIA THE LEFT GROIN USING A CUT DOWN TECHNIQUE THE CLINICIAN COULD NOT REMOVE THE INTRODUCER FROM THE CATHETER BODY ( LS96360-025 MULTISTAGE DRAINAGE CATHETER). THE CLINICIAN COULD ONLY RETRACT THE INTRODUCER BY APPROXIMATELY 10CM. THE DECISION WAS MADE TO REPLACE THE CANNULA WITH ANOTHER LS96360-025 AND THE EXACT SAME ISSUE RESULTED. THE CLINICIAN THEN DECIDED TO CANNULATE USING A LIVANOVA RAP CANNULA AND THIS WAS SUCCESSFUL. THE PATIENTS VESSEL WAS DILATED USING THE LIVANOVA ACCESS KIT TO 24FR DILATION PRIOR TO CANNULATION. THE CANNULA BODY WAS WETTED OUT USING SALINE PRIOR TO INTRODUCING THE WHITE INTRODUCER (CUSTOMER PROTOCOL). THE CUSTOMER ASKED IF THE ELASTEON MATERIAL OF THE BIOMEDICUS LIFE SUPPORT CATHETER HAS ANY IMPACT ON FRICTION BETWEEN THE CATHETER BODY AND THE WHITE INTRODUCER MATERIAL. (PLEASE DETAIL THE INTRODUCER MATERIAL IN THE REPORT). THE CUSTOMER ASKED FOR A DETAILED CHECK ON ANY MANUFACTURING VARIANCE ON THE CANNULA BODY AND THE WHITE INTRODUCER. ARE THEY WITHIN SPECIFICATION AND WHAT IS THAT SPECIFICATION (WAS ONE AT THE TOP E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759175 ↗
• MalfunctionJun 2, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THAT THE CONNECTOR WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048781 ↗