Bio-Medicus® 96370-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994504777), received between Jul 21, 2025 and Jul 21, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Mechanical Problem; Misassembled During Installation; Mechanical Problem; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE-PIECE FEMORAL VENOUS CANNULA, IT WAS REPORTED THAT THE ECMO (EXT RACORPOREAL MEMBRANE OXYGENATION) RETRIEVAL TEAM PICKED UP THE PATIENT FROM A REGIONAL SERVICE. THE RETRIEVAL TEAM CANNULATED THE PATIENT TO COMMENCE ECMO. HOWEVER, THEY DISCOVERED THAT THEY COULD NOT CONNECT THE CANNULA TO THE ECMO CIRCUIT DUE TO A HALF-INCH CONNECTOR, RATHER THAN THE STANDARD 3/8 CONNECTOR. THE PATIENT HAD TO BE RE-CANNULATED WITH A DIFFERENT CANNULA THAT HAD A 3/8 CONNECTOR. THE PATIENT WAS SUCCESSFULLY ATTACHED TO THE ECMO CIRCUIT. THE PATIENT WAS A CRITICALLY UNWELL PATIENT. 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 22553503 ↗

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.