Bio-Medicus™ CB96670-019 (UDI 00643169696716)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169696716), received between Mar 26, 2020 and Mar 26, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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.

• MalfunctionMar 26, 2020Inaccurate Information; Inaccurate Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED IN THE PROCESS OF ARTERIOVENOUS INTUBATION, THE SPECIFICATION AND MODEL OF THE CHINESE LABEL REGISTRATION CERTIFICATE FOR THE BIO-MEDICUS ADULT FEMORAL CANNULA (CB96670-019) WAS INCORRECT. THE PHYSICAL LABEL WAS 15FR, WHICH SHOULD HAVE BEEN 19FR. THE PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE AFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9882104 ↗

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.