Bio-Medicus™ 96600-123 (UDI 00763000060565)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000060565), received between Nov 14, 2023 and Aug 7, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 18, 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.

• MalfunctionAug 7, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT THE WIRE THAT WAS PROVIDED WITH THE CANNULA WAS UNABLE TO BE PASSED THROUGH THE OBTURATOR OF THE CANNULA AS WELL AS THE LARGEST DILATOR. A NEW CANNULA WAS OPENED AND THE SAME WIRE WAS USED SUCCESSFULLY IN THE NEW CANNULA OBTURATOR AND DILATOR WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19926852 ↗
• MalfunctionNov 23, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT UPON OPENING THE CANNULA, THE SCRUB TECHNICIAN NOTICED A CRACK ON THE CONNECTOR OF THE DEVICE. SEE ATTACHED PHOTOS/VIDEO. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18198339 ↗
• MalfunctionNov 14, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, THE CUSTOMER REPORTED THAT THERE WAS A CRACK IN THE CONNECTOR. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130161 ↗

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