Bio-Medicus™ 96670-123 (UDI 00643169025967)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169025967), received between Aug 24, 2022 and Jan 8, 2026 — classified as 1 death, 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULAE WERE MISSING THE BASKET HOLES. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LABELS ON THE PACKAGING DOES NOT EXACTLY MATCH THE DEVICES INSIDE. THE MODEL NUMBER OF THE DEVICES ARE CORRECT HOWEVER, THEY ARE MISSING THE SIDE HOLES ON THE MAIN BODY OF THE CANNULAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001581 ↗
• MalfunctionJan 8, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULAE WERE MISSING THE BASKET HOLES. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LABELS ON THE PACKAGING DOES NOT EXACTLY MATCH THE DEVICES INSIDE. THE MODEL NUMBER OF THE DEVICES ARE CORRECT HOWEVER, THEY ARE MISSING THE SIDE HOLES ON THE MAIN BODY OF THE CANNULAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001557 ↗
• MalfunctionJan 8, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULAE WERE MISSING THE BASKET HOLES. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LABELS ON THE PACKAGING DOES NOT EXACTLY MATCH THE DEVICES INSIDE. THE MODEL NUMBER OF THE DEVICES ARE CORRECT HOWEVER, THEY ARE MISSING THE SIDE HOLES ON THE MAIN BODY OF THE CANNULAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001543 ↗
• MalfunctionJan 8, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULAE WERE MISSING THE BASKET HOLES. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LABELS ON THE PACKAGING DOES NOT EXACTLY MATCH THE DEVICES INSIDE. THE MODEL NUMBER OF THE DEVICES ARE CORRECT; HOWEVER, THEY ARE MISSING THE SIDE HOLES ON THE MAIN BODY OF THE CANNULAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001532 ↗
• MalfunctionJan 8, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULAE WERE MISSING THE BASKET HOLES. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LABELS ON THE PACKAGING DOES NOT EXACTLY MATCH THE DEVICES INSIDE. THE MODEL NUMBER OF THE DEVICES ARE CORRECT HOWEVER, THEY ARE MISSING THE SIDE HOLES ON THE MAIN BODY OF THE CANNULAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001509 ↗
• MalfunctionNov 13, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, THE CUSTOMER REPORTED THAT THERE WERE SUBTLE CURVES OBSERVED ON THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BEND IS LOCATED NEAR THE UPPER HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117905 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, THE CUSTOMER REPORTED A CONNECTOR LEAK. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17727365 ↗
• MalfunctionMay 29, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT THERE WAS A LITTLE CRACK/TEAR ON THE PROXIMAL CONNECTOR SIDE. THE DEVICE WAS REPLACED, HOWEVER THE SECOND DEVICE ALSO HAD THE SAME CRACK/TEAR ON THE CONNECTOR. THE SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CRACK WAS DETECTED WHEN OPENING THE STERILIZATION PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016589 ↗
• MalfunctionMay 23, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT THERE WAS A SMALL CRACK/TEAR ON THE PROXIMAL CONNECTOR SIDE. THE DEVICE WAS REPLACED, HOWEVER THE SECOND DEVICE ALSO HAD THE SAME CRACK/TEAR ON THE CONNECTOR. THE SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CRACK WAS DETECTED WHEN OPENING THE STERILIZATION PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985547 ↗
• DeathMay 10, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF TWO BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULAE, IT WAS REPORTED THAT THE JUGULAR CANNULA DETACHED FROM THE PATIENT, WHICH CAUSED THEIR DEATH. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH LUNG FAILURE, AND WAS CONNECTED TO ECMO (VV FEM-JUGULAR). THE BIO-MEDICUS CANNULAE WERE BEING USED FOR DRAINAGE AND RETURN. ADDITIONAL INFORMATION RECEIVED CONFIRMS THE CAUSE OF DEATH WAS BLEEDING. THE PATIENT'S DEATH IS BELIEVED TO BE LINKED TO THE PERFORMANCE OF THE JUGULAR CANNULA ONLY (96570-119). AFTER THE CANNULA DETACHED FORM THE PATIENT, THE HEALTH CARE PROFESSIONAL PERFORMED RESUSCITATION. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE THE CANNULA WAS SECURED WITH A FEW WAYS- IT WAS SUTURED WITH SUTURES AND BANDAGE. THE HOSPITAL IS INVESTIGATING IF THE CANNULA BECOMING DETACHED CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. NO FURTHER INFORMATION IS AVAILABLE ON THE SEQUENCE OF EVENTS LEADING TO THE CANNULA BECOMING DETACHED. THE PATIENT WAS ON ECMO FOR SEVEN DAYS. THERE IS NO ALLEGATION AGAINST THE DEVICE AND THERE WERE NO CANNULA DEFECTS NOTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16900929 ↗
• InjuryAug 24, 2022Material Deformation; Air/Gas in Device; Material Deformation; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL VENOUS CANNULA, IT WAS REPORTED THAT AFTER THE CANNULATION, THE CUSTOMER NOTICED THAT THE CANNULA WAS DAMAGED AND THAT AIR WAS ENTERING THE CANNULA THROUGH IT. THE DAMAGE WAS CLOSED WITH STERNUM WAX AND THE PROCEDURE CONTINUED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE SALES REP STATED THAT THEY SUSPECTED MECHANICAL DAMAGE DURING CANNULATION. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO LEAK OBSERVED FROM THE CANNULA. THE CUSTOMER STATED THAT THERE WAS NO BLOOD WAS LEAKING, BUT AIR WAS COMING IN AND A TRANSFUSION WAS NOT REQUIRED. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. IT IS UNKNOWN WHETHER THERE WAS DAMAGE IN THE LOCATION OF THE SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281381 ↗