Bio-Medicus™ 96600-121 (UDI 00763000116163)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000116163), received between Dec 2, 2025 and Dec 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Component Missing; Device Markings/Labelling Problem; Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THREE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULAE WERE IDENTIFIED AS BI-CAVAL RATHER THAN MULTISTAGE, INDICATING A MISSING COMPONENT OR POSSIBLE INCORRECT CANNULA IN THE BOX OR CANNULA BODY PRIOR TO USE. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692623 ↗
• MalfunctionDec 2, 2025Component Missing; Device Markings/Labelling Problem; Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THREE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULAE WERE IDENTIFIED AS BI-CAVAL RATHER THAN MULTISTAGE, INDICATING A MISSING COMPONENT OR POSSIBLE INCORRECT CANNULA IN THE BOX OR CANNULA BODY PRIOR TO USE. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692569 ↗
• MalfunctionDec 2, 2025Component Missing; Device Markings/Labelling Problem; Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THREE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULAE WERE IDENTIFIED AS BI-CAVAL RATHER THAN MULTISTAGE, INDICATING A MISSING COMPONENT OR POSSIBLE INCORRECT CANNULA IN THE BOX OR CANNULA BODY PRIOR TO USE. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692518 ↗

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