BioMedicus™ 96570-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169025752), received between Feb 4, 2022 and Jul 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 15, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A 96570 BIO-MEDICUS NEXTGEN FEMORAL VENOUS CANNULA, THE CUSTOMER REPORTED THAT THERE WAS A MEDIUM CRACK ON THE CONNECTOR. PRODUCT WAS IN THE DOCTOR'S HAND WHEN SEEN, PRIOR TO USE. IT WAS CONFIRMED THAT THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929642 ↗
• MalfunctionFeb 4, 2022Crack; Fracture; Crack; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF A BIO-MEDICUS 21FR NEXTGEN ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT WHEN THE CANNULA WAS INSERTED INTO THE PATIENT, THE CUSTOMER OBSERVED THAT THE CONNECTOR WAS COMPLETELY BROKEN AND DEFORMED AND THE CANNULA WAS REMOVED. THE CUSTOMER REPORTED THAT THE CANNULA HAD TO BE REPLACED AND DURING THE TRANSITION, THERE WAS MODERATE BLOOD LOSS HOWEVER A CANNULA IS CURRENTLY IN PLACE AND THE PATIENT IS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE CUSTOMER HAS STATED THAT THE DEVICE WAS DISCARDED DUE TO THE PATIENT'S "COVID POSITIVE" STATUS. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THAT IT IS INITIALLY DIFFICULT TO NOTICE THE DEFECT BECAUSE AS SOON AS THE SURGEON INSERTS THE OBTURATOR INTO THE CANNULA FOR INSERTION, THAT CONNECTOR IS COVERED WITH A PLASTIC COVER UNTIL IT IS INSIDE THE PATIENT AND IS CONNECTED TO THE EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) LINES. THE CUSTOMER REPORTED THAT THEY OBSERVED AS THE ECMO FELLOW INSERTED THE CANNULA AND REPORTED THAT THERE WAS NO USER ERROR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451094 ↗