Bio-Medicus Life SupportRecalls & reported problems across all models

We found 16 models of Bio-Medicus Life Support by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2023 and Sep 30, 2026 — classified as 1 death, 1 injury, 49 malfunctions.

The most frequently reported specific device problem is “Crack” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bio-Medicus Life Support problems

Bio-Medicus Life Support models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bio-Medicus Life Support™ LS96218-017

  Single lumen ECMO cannula
  8 reports
• Bio-Medicus Life Support™ LS96555-019

  Single lumen ECMO cannula
  7 reports
• Bio-Medicus Life Support™ LS96218-019

  Single lumen ECMO cannula
  5 reports
• Bio-Medicus Life Support™ LS96360-025

  Single lumen ECMO cannula
  5 reports
• Bio-Medicus Life Support™ LS96218-015

  Single lumen ECMO cannula
  4 reports
• Bio-Medicus Life Support™ LS96555-021

  Single lumen ECMO cannula
  4 reports
• Bio-Medicus Life Support™ LS96218-021

  Single lumen ECMO cannula
  3 reports
• Bio-Medicus Life Support™ LS96555-023

  Single lumen ECMO cannula
  3 reports
• Bio-Medicus Life Support™ LS96360-023

  Single lumen ECMO cannula
  3 reports
• Bio-Medicus Life Support™ LS96550-017

  Single lumen ECMO cannula
  2 reports
• Bio-Medicus Life Support™ LS96360-029

  Single lumen ECMO cannula
  1 death2 reports
• Bio-Medicus Life Support™ LS96010-009

  Single lumen ECMO cannula
  1 report
• Bio-Medicus Life Support™ LS96550-015

  Single lumen ECMO cannula
  1 report
• Bio-Medicus Life Support™ LS96555-025

  Single lumen ECMO cannula
  1 report
• Bio-Medicus Life Support™ LS96438-025

  Single lumen ECMO cannula
  1 report
• Bio-Medicus Life Support™ LS96360-027

  Single lumen ECMO cannula
  1 report

Recent Bio-Medicus Life Support adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  It was reported that during insertion of a Bio-Medicus Life Support cannula, there was difficulty removing the cannula dilator. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949247 ↗
• 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 ↗
• MalfunctionSep 2, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559965 ↗
• 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 ↗
• MalfunctionMay 14, 2026Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CATHETER , THE CUSTOMER REPORTED A CRACK ON THE CATHETER CONNECTOR. THE CRACK WAS DESCRIBED AS THE LENGTH OF THE CONNECTOR AND THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171347 ↗
• MalfunctionMay 6, 2026Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE DEVICE HAD A BROKEN TIP. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. IT WAS DIFFICULT TO REMOVE AFTER THE RESISTANCE WITH PASSING OVER WIRE. 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 25096083 ↗
• MalfunctionMar 25, 2026Mechanical Problem; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688899 ↗
• InjuryJan 27, 2026Crack; Material Deformation

  IT WAS REPORTED THAT AFTER A PATIENT WAS PLACED ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) IN THE INTENSIVE CARE UNIT (ICU), A BIO-MEDICUS LIFE SUPPORT CATHETER AND INTRODUCER WAS INSERTED AND A BROKEN DEFECT WAS OBSERVED IN THE MOST PROXIMAL PART OF THE HARD PLASTIC CONNECTOR TO THE TUBING. THE CANNULA WAS NOT CHANGED DUE TO THE PATIENT¿S CIRCUMSTANCES, AND CONNECTING THE TUBING DID NOT CAUSE ANY PROBLEMS AS THE CONNECTOR WAS SECURED WITH A CABLE TIE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE CANNULA WAS DELIVERED IN A BACK PACK AS THEY HAD TO CANNULATE IN ANOTHER HOSPITAL. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE CUSTOMER CANNULATED BY PLACING THE WHITE INTRODUCER INSIDE WITHOUT APPLYING ANY SPECIAL FORCE. WHEN THEY WERE ABOUT TO CONNECT THE TUBING, THEY NOTICED A CLEAR BREAK IN THE MOST PROXIMAL PART OF THE CANNULA, WHICH APPEARED WHITISH. THE BREAK DID NOT REACH THE END. SINCE THERE WAS A MARGIN THAT WAS NOT BROKEN, THEY DECIDED TO CONNECT THE TUBING AND PROCEED WITH ECMO, AND THEN A MO

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188188 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE CONNECTOR OF THE BIO-MEDICUS LIFE SUPPORT CANNULA DID NOT CLOSE PROPERLY AND THE SHAPE OF THE CONNECTOR WAS UNUSUAL. THE CONNECTOR WAS REPLACED, AFTER WHICH IT FUNCTIONED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987960 ↗
• DeathDec 2, 2025Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CATHETER AND INTRODUCER, IT WAS REPORTED THAT WHILE A PATIENT WAS BEING TREATED WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), WHILE AWAITING POSSIBLE TRANSPLANT OR VENTRICULAR ASSIST DEVICE (VAD) PLACEMENT. DURING MOVEMENT FOR COMPUTED TOMOGRAPHY IMAGING (CT), THE DEVICE USED TO CANNULATE THE NECK BECAME DISLODGED, RESULTING IN AIR ENTERING THE VENOUS LINE AND BLEEDING. AN UNPLANNED TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE BLOOD LOSS. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED BUT WAS UNSUCCESSFUL, AND THE PATIENT DIED. ADDITIONALLY, THE CUSTOMER STATED THAT THE PROCEDURE CAUSED OR CONTRIBUTED TO THE DEATH. THE MEDTRONIC DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

  Patient problems: Air Embolism; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23693445 ↗
• MalfunctionNov 27, 2025Crack; Crack

  IT WAS REPORTED THAT A CRACK WAS IDENTIFIED ON THE PLASTIC PART OF THE CONNECTOR AT THE OPENING OF THE BIO-MEDICUS LIFE SUPPORT CATHETER AND INTRODUCER PRIOR TO USE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665813 ↗
• MalfunctionAug 5, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, WHILE THE CANNULA WAS INSERTED INTO THE FEMORAL VEIN OF THE PATIENT THE CUSTOMER COULD NOT REMOVE THE DILATOR FROM THE SHEATH. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22712517 ↗
• 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 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 ↗

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