Bio-Medicus™ CB96570-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000193386), received between Jun 22, 2023 and Jan 22, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 16, 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.

• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIOMEDICUS CANNULA, IT WAS REPORTED THAT AFTER THE OUTER PACKAGE WAS OPENED, THEY FOUND THAT THE DEVICE WAS NOT IN A STERILE SEAL, AND DID NOT MEET STERILITY REQUIREMENTS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143315 ↗
• MalfunctionMar 8, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, IT WAS REPORTED THAT THE CANNULA WAS INSERTED INTO THE PATIENT AND IT COULD NOT BE INSERTED INTO THE PROPER POSITION. THE CUSTOMER DECIDED TO TAKE IT OUT OF THE PATIENT AND THEN HE FOUND THE DEFORMATION AT CANNULAE TIP'S PROXIMAL END. 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 18863710 ↗
• MalfunctionJun 22, 2023Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO ADVANCE AN ECMO CANNULA INTO THE FEMORAL ARTERY. THERE WAS A SMALL BULGED AREA ON THE DISTAL END OF THE CANNULA. THIS SMALL DEFECT PREVENTED THE CANNULA FROM FITTING INTO THE FEMORAL ARTERY. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180313 ↗