Bio-Medicus™ 96600-125 (UDI 00763000116187)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000116187), received between Dec 1, 2025 and Jan 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

• MalfunctionJan 7, 2026Obstruction of Flow; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA, THERE WERE ISSUES WITH DRAINAGE AND THE INCORRECT CANNULA TYPE WAS USED, AS A BI-CAVAL 25FR OLD STYLE CANNULA WAS UTILIZED INSTEAD OF THE INTENDED NEX GEN MULTISTAGE CANNULA AS THE BOX WAS FOR A BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA, HOWEVER, THE DEVICE ITSELF WAS A BI-CAVAL 25FR OLD STYLE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987724 ↗
• MalfunctionDec 1, 2025Obstruction of Flow; Device Markings/Labelling Problem; Misassembled During Installation; Obstruction of Flow; Device Markings/Labelling Problem; Misassembled During Installation

  IT WAS REPORTED THAT THE WRONG BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA WAS DELIVERED AND PLACED DURING A PROCEDURE, RESULTING IN INADEQUATE PERFUSION AND LOWER FLOWS FOR THE PATIENT DURING USE. THE SURGEON PLACED THE DEVICE IN A HURRY; HOWEVER, THE DESIGN OF THE CANNULA DID NOT ALLOW FOR ADEQUATE DRAINAGE, WHICH CONTRIBUTED TO THE ISSUE. THE 96600-125 MULTI CANNULA AND BI-CAVALCANNULA HAVE SAME THE CFN BUT DIFFERENT GTIN. THE GTIN WAS OBSOLETED FOR THE NETHERLANDS. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THEY COULD NOT REPLACE THE DEVICE WHILE BEING ON PERFUSION. THERE WAS NO IMPACT TO THE PATIENT DUE TO THE INADEQUATE PERFUSION. THERE WAS A MISTAKE MADE AT EOC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680023 ↗
• MalfunctionDec 1, 2025Obstruction of Flow; Misassembled During Installation; Obstruction of Flow; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA AND KITS, IT WAS REPORTED THIS DEVICE HAS A MULTI AND BI CAVAL SPEC, AND THE WRONG CANNULA (BI CAVAL) WAS DELIVERED TO THE CUSTOMER, DESPITE THE FACT THAT THE GTIN WAS OBSOLETED/ON BLOCK FOR NETHERLANDS. THE SURGEON HURRIEDLY PLACED THE DEVICE INTO THE PATIENT, BUT DUE TO DESIGN DIFFERENCE AND WRONG DEVICE BEING DELIVERED, WAS UNABLE TO DRAIN THE PATIENT ADEQUATELY. THIS LED TO A LOW FLOW ISSUE AND AN INADEQUATE PERFUSION. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679701 ↗

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