BioMedicus™ 96670-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169025950), received between Jan 10, 2025 and Feb 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 10 most recent of 10 reports, 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 ↗
• 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 ↗