Bio-Medicus® 96670-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994504616), received between Jul 11, 2025 and Jan 21, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 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.

• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FEMORAL VENOUS CANNULA AND INTRODUCER, IT WAS REPORTED THAT THE INNER PACKAGING OF THE PRODUCT WAS DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ASEPTIC SEALED PACKAGE OF THIS COMPLAINT PRODUCT WAS DAMAGED, AND THERE WERE NO OTHER PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130597 ↗
• MalfunctionJul 11, 2025Crack; Crack

  IT WAS REPORTED THAT AFTER OPENING THE OUTER PACKAGING OF THE BIO-MEDICUS FEMORAL VENOUS CANNULA WITH AN INTRODUCER PRIOR TO USE, CR ACKS WERE OBSERVED ON THE CANNULA. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477677 ↗

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.