Bio-Medicus™ CB96345-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000193195), received between May 17, 2024 and Jun 25, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K924642); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE OBTURATOR LOOKED DIFFERENT THAN NORMAL. THE COMPONENT APPEARED DEFORMED AND ROUNDED-OFF. THERE WAS NO DAMAGE TO THE PACKAGING. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. 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 19604552 ↗
• MalfunctionMay 17, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED A DEFORMATION AT THE PROXIMAL END OF THE CANNULA TIP WHILE INSERTING THE DEVICE INTO THE PATIENT. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). 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 19338952 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924642. One submission often covers many models, so check the product and lot details in each record.

• Z-1928-2008 · May 9, 2008 · Terminated
  Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numbers: CB96345-023, CB96345-023, and CB96345-029.