BioMedicusRecalls & reported problems across all models

We found 5 models of BioMedicus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Feb 4, 2022 and Feb 27, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Crack” (10 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 BioMedicus problems

BioMedicus models

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

• BioMedicus™ 96670-125

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  10 reports
• BioMedicus™ 96670-121

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  8 reports
• BioMedicus™ 96570-117

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  6 reports
• BioMedicus™ 96570-121

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  3 reports
• BioMedicus™ 96670-117

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  3 reports

Recent BioMedicus adverse event reports

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

• MalfunctionFeb 27, 2026Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA HAD AN INCORRECT CANNULA BODY. THE DEVICE WAS NOT USED. THE PACKAGING WAS NOT DAMAGED, AND OTHER DEVICES IN THE SAME BOX OR SHIPPING CONTAINER WERE NOT AFFECTED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA DOES NOT MATCH THE LABEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470110 ↗
• MalfunctionFeb 27, 2026Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA HAD AN INCORRECT CANNULA BODY. THE DEVICE WAS NOT USED. THE PACKAGING WAS NOT DAMAGED, AND OTHER DEVICES IN THE SAME BOX OR SHIPPING CONTAINER WERE NOT AFFECTED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA DOES NOT MATCH THE LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470088 ↗
• MalfunctionFeb 27, 2026Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA HAD AN INCORRECT CANNULA BODY. THE DEVICE WAS NOT USED. THE PACKAGING WAS NOT DAMAGED, AND OTHER DEVICES IN THE SAME BOX OR SHIPPING CONTAINER WERE NOT AFFECTED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA DOES NOT MATCH THE LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470081 ↗
• MalfunctionFeb 27, 2026Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA HAD AN INCORRECT CANNULA BODY .THE DEVICE WAS NOT USED. THE PACKAGING WAS NOT DAMAGED, AND OTHER DEVICES IN THE SAME BOX OR SHIPPING CONTAINER WERE NOT AFFECTED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA DOES NOT MATCH THE LABEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470028 ↗
• MalfunctionFeb 27, 2026Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA HAD AN INCORRECT CANNULA BODY. THE DEVICE WAS NOT USED. THE PACKAGING WAS NOT DAMAGED, AND OTHER DEVICES IN THE SAME BOX OR SHIPPING CONTAINER WERE NOT AFFECTED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA DOES NOT MATCH THE LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469834 ↗
• MalfunctionFeb 17, 2026Misassembled During Installation

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA HAD AN INCORRECT CANNULA BODY AND A QUALITY ISSUE PRIOR TO USE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONTENTS/DEVICE IN THE PACKAGING DID NOT MATCH THE LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363901 ↗
• MalfunctionFeb 13, 2026Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA HAD AN INCORRECT CANNULA BODY. THE DEVICE WAS NOT USED. THE PACKAGING WAS NOT DAMAGED, AND OTHER DEVICES IN THE SAME BOX OR SHIPPING CONTAINER WERE NOT AFFECTED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331258 ↗
• MalfunctionNov 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT DURING THE INSTALLATION OF PERIPHERAL VENOARTERIAL EXTRA-CORPOREAL MEMBRANE OXYGENATION (VA-ECMO), IT WAS NOTED THAT THE SECONDARY PACKAGING OF THE CANNULA WAS BREACHED WITH A HOLE, COMPROMISING STERILITY. THE DEVICE WAS NOT USED, THEREFORE, IT DID NOT PRESENT DAMAGE TO THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS NOT USED ON THE PATIENT, THUS AVOIDING ANY HARM TO THE PROCEDURE. THE MATERIAL WAS REPLACED WITH ANOTHER CANNULA FROM ANOTHER MANUFACTURE. THERE WERE NO MISSING COMPONENTS IN THE PACKAGING; THE ONLY ISSUE WAS THE HOLE IN THE SECONDARY PACKAGING, WHICH COMPROMISED STERILITY. THE STERILE SEAL WAS INTACT. THE DEVICE HAD INTACT PACKAGING, WITH ONLY A HOLE IN THE SECONDARY PACKAGING. IT WAS STATED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476727 ↗
• MalfunctionJul 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF THESE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULAE, THE WHITE MANDREL DID NOT SLIDE INTO THE CANNULAE, PREVENTING IT FROM BEING PULLED OUT. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395296 ↗
• MalfunctionJul 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF THESE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULAE, THE WHITE MANDREL DID NOT SLIDE INTO THE CANNULAE, PREVENTING IT FROM BEING PULLED OUT. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395289 ↗
• MalfunctionJan 23, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE OF BIO-MEDICUS LIFE SUPPORT CANNULAE, UPON OPENING THE PRODUCT THE CUSTOMER EXPERIENCED DIFFICULTY WITH THE INTRODUCER, WHICH COULD NOT BE REMOVED FROM THE CATHETER BODY DUE TO IT BEING STICKY/HIGH FRICTION AT A SPECIFIC POINT. THE CUSTOMER DECIDED TO CHECK OTHER MULTISTAGE FEMORAL VENOUS CANNULA IN THEIR STOCK. THEY OBSERVED THE SAME ¿NON-PERFECT CIRCLE¿ ON THE CANNULA BODY TIP ON MOST OF THE CANNULAE IN THEIR STOCK. THEY OPENED TWO EXPIRED DEVICES AND CHECKED IF THE INTRODUCER WAS STICKY UPON REMOVING AROUND 7-10CM. IT WAS CONFIRMED THEY WERE STICKY. THIS WAS NOTED ON THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) LIFE SUPPORT RANGE AS WELL AS THE BIO-MEDICUS NEXT GEN MULTISTAGE CANNULAE. THEY ALSO REMOVED FROM THE HOSPITAL AN EXPIRED MULTI AND ALSO AN EXPIRED OLD GEN BI-CAVAL AND THEY WERE BOTH ¿SLIGHTLY STICKY¿ AT THE 7-10CM AREA WHEN REMOVING THE INTRODUCER. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WITH THE CANNULAE TIP SHAPES WAS AN OBSERVATION DURING CHECKING OTHER STOCK AT THE CUSTOMER SITE. THE CUSTOMER QUERIED WHETHER THIS WAS NORMAL AND COULD IT BE PLAYING A PART IN THE INTRODUCER STICKING EVENTS. THE FIRST BIO-MEDICUS LI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216241 ↗
• MalfunctionJan 10, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, UPON OPENING THE PRODUCT THE CUSTOMER EXPERIENCED DIFFICULTY WITH THE INTRODUCER, WHICH COULD NOT BE REMOVED FROM THE CATHETER BODY DUE TO IT BEING STICKY/HIGH FRICTION AT A SPECIFIC POINT. THE CANNULA BODY WAS WETTED WITH SALINE PRIOR TO INTRODUCING THE WHITE INTRODUCER, FOLLOWING CUSTOMER PROTOCOL. THE INTRODUCER COULD ONLY BE RETRACTED BY APPROXIMATELY 7-10 CM BEFORE STICKING. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT UPON VISUAL INSPECTION OF THE CANNULA, THE CUSTOMER NOTED THAT WHEN THE INTRODUCER WAS REMOVED FROM THE CANNULA, THE CANNULA TIP WAS NOT A PERFECT CIRCLE. THE EXTERNAL PACKAGING AND THE PROTECTIVE TUBE HOLDING THE CANNULA FOR SHIPPING DID NOT SHOW DAMAGE. THE CUSTOMER DECIDED TO CHECK OTHER MULTISTAGE FEMORAL VENOUS CANNULA IN THEIR STOCK. THEY OBSERVED THE SAME ¿NON-PERFECT CIRCLE¿ ON THE CANNULA BODY TIP ON MOST OF THE CANNULAE IN THEIR STOCK. THEY OPENED TWO EXPIRED DEVICES AND CHECKED IF THE INTRODUCER WAS STICKY UPON REMOVING AROUND 7-10CM. IT WAS CONFIRMED THEY WERE STICKY. THIS WAS NOTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122822 ↗
• MalfunctionDec 11, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, WHEN PLANNING ON INTRODUCING THE DEVICE, THE CUSTOMER REALIZED THAT THE GUIDEWIRE WOULD NOT PASS THROUGH THE INTRODUCER HOLE AS THERE SEEMED TO BE A BLOCK INSIDE THE INTRODUCER. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901047 ↗
• MalfunctionNov 27, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS CANNULA, IT WAS REPORTED THE CUSTOMER DETECTED A CRACK ON THE CONNECTOR WHEN OPENING THE STERILIZATION PACKAGING. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211930 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS BIO-MEDICUS 21FR NEXTGEN ARTERIAL CANNULA THE CUSTOMER NOTICED THAT THE BONDED CONNECTOR WAS COMPROMISED STRAIGHT OUT OF THE PACKAGE. THE CANNULA WAS NOTED TO HAVE WHITE MARKINGS THAT ALMOST APPEARED AS IF THE CONNECTOR HAD BEEN CLAMPED, BUT IT WAS NOT. THAT CONNECTOR IN PARTICULAR WAS STILL INTACT AND PERFECTLY CIRCULAR WITH NO RAGGED EDGES SO THE CUSTOMER PROCEEDED WITH USING IT AS IT WAS ALREADY IN THE PATIENT WHEN THEY NOTICED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE. THE CUSTOMER STATED THAT THE PATIENT IS FINE AND THERE IS NO CLAIM OF ADVERSE EVENTS. ADDITIONAL INFORMATION: THERE WAS NO BLOOD LOSS AS A RESULT OF THIS ISSUE. THERE WAS NO VISIBLE AIR IN THE CANNULA REPORTED. THE CUSTOMER STATED THAT IT WAS INITIALLY DIFFICULT TO NOTICE THE DEFECT BECAUSE AS SOON AS THE SURGEON INSERTED THE OBTURATOR INTO THE CANNULA FOR INSERTIO N, THAT CONNECTOR WAS COVERED WITH A PLASTIC COVER UNTIL IT WAS INSIDE THE PATIENT AND CONNECTED TO THE EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) LINES. THE CUSTOMER REPORTED THAT THE ECMO FELLOW WHO INSERTED THE CANNULA, CLAIMED THEY DID NOT CLAMP THE DEVICE OR MANIPULATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262487 ↗

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