Bio-Medicus™ CB96570-015 (UDI 00643169969346)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169969346), received between Jan 6, 2023 and Jan 6, 2023 — classified as 1 malfunction.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS ONE-PIECE FEMORAL ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THE DEVICE HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LENGTH OF THE CRACK WAS ABOUT 3 TO 4 CM. THE POSITION WHERE THE ARTERIOVENOUS CANNULA CB96570-015 WAS CONNECTED TO THE HEPARIN CAP HAD A CRACK INSIDE AFTER OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110864 ↗

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.