Bio-Medicus™ 96600-121 (UDI 00763000060558)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000060558), received between Dec 11, 2024 and Dec 11, 2024 — 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 (K180456); 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.

• MalfunctionDec 11, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA KIT, IT WAS REPORTED THAT THE CUSTOMER WAS TRYING TO PASS THE DILATOR THROUGH THE CANNULA, BUT IT WAS GETTING STUCK AT THE TOP AND THEY WERE UNABLE TO PASS IT. THE CUSTOMER OPENED ANOTHER CANNULA OF THE SAME SIZE AND WERE ABLE TO PASS THE DILATOR NO PROBLEM. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. NO DAMAGE WAS NOTED TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901289 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180456. One submission often covers many models, so check the product and lot details in each record.

• Z-2738-2026 · May 25, 2026 · Open, Classified
  Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula