Bio-Medicus™ CB96535-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000032371), received between May 3, 2019 and May 3, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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.

• InjuryMay 3, 2019Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION, THAT DURING USE THE CUSTOMER REPORTED THE BIO-MEDICUS ONE-PIECE FEMORAL CANNULA SPLIT/BROKE, RESULTING IN A LARGE BLOOD LOSS REQUIRING TWO TRANSFUSIONS. IN ADDITION, SOME BLOOD SPLASHED OVER THE PHYSICIANS FACES. THE CUSTOMER CONFIRMED THERE WAS NO IMPACT TO THE PHYSICIANS. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT (ALIVE - NO INJURY). ADDITIONAL INFORMATION WAS RECEIVED FROM THE FACILITY INDICATING THE INITIAL PATIENT CONDITION REQUIRED VENOARTERIAL ECMO FOR MALIGNANT ARRHYTHMIA. THE PATIENT WAS TRANSFERRED FROM RVH ED TO CATH LAB RIGHT FEMORAL ARTERIAL AND VENOUS ACCESS IN SITU. INTRODUCERS (VEIN AND ARTERY) EXCHANGED MRE AND ARTERIAL VENOUS ECMO CANNULAE INSERTED. 5 MINUTES AFTER COMMENCEMENT OF ECMO, A SPONTANEOUS FRACTURE OF THE ARTERIAL CANNULA OCCURRED, RESULTING IN A LARGE BLOOD LOSS REQUIRING TRANSFUSION PROTOCOL TWICE.

  Patient problems: Exsanguination

  MAUDE report 8576886 ↗

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