BIO-MEDICUS® 96600-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994490094), received between Mar 14, 2022 and Mar 14, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K884129); 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 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED THAT THE CANNULA WAS DAMAGED AND THAT THE CANNULA WAS LEAKING BLOOD FROM THE CONNECTION BETWEEN THE CANNULA AND A CONNECTOR. THE CANNULA WAS INSERTED IN THE FEMORAL VEIN. IT WAS ASKED BUT UNKNOWN HOW MUCH BLOOD WAS LOST DUE TO THE LEAK. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE, AND THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13756174 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K884129. One submission often covers many models, so check the product and lot details in each record.

• Z-1929-2008 · May 9, 2008 · Terminated
  Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015