Bio-Medicus™ 96570-017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169880771), received between Dec 20, 2021 and Mar 10, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K924642); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 17 FR BIO-MEDICUS CANNULA, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ACUTE MYOCARDIAL INFARCTION. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TREATMENT WAS REQUIRED TO SUPPORT HEART FUNCTION DUE TO THE CONDITION. THE PHYSICIAN STARTED TO PLACE THE CANNULA AT 18:40 ON (B)(6) 2025. BEFORE THE CANNULA WAS PLACED, TWO NURSES CHECKED THAT THE PACKAGING WAS INTACT AND WITHIN THE VALIDITY PERIOD. THERE WAS 0.9% SODIUM CHLORIDE INJECTION USED TO FLUSH THE CANNULA AND CHECK THE PIPELINE. IT WAS UNOBSTRUCTED AND THERE WAS NO LIQUID LEAKAGE IN THE PIPELINE. AFTER THE PHYSICIAN PLACED THE CANNULA, THE ECMO MACHINE STARTED TO OPERATE AT 20:00 ON (B)(6) 2025. AFTER THE BLOOD WAS DRAWN FROM THE ARTERIAL END, BLOOD WAS FOUND TO BE OOZING OUT AT THE END OF THE ARTERIAL END. AFTER WIPING WITH STERILE GAUZE, THERE WAS STILL BLOOD OOZING OUT. STERILE GAUZE WAS IMMEDIATELY USED TO COMPRESS AND STOP THE BLEEDING. THE BLOOD OOZING WAS REDUCED TO STOP. THE PHYSICIAN CONTINUED TO USE IT AND OBSERVED CLOSELY. IF THE PIPELINE CONTINUED TO OOZE OUT, THERE WAS THE POSSIBILITY OF INFECTION. IF BLOOD LOSS WAS TOO MUCH, IT WOULD ENDANGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558366 ↗
• InjuryDec 20, 2021Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED THAT WHILST CHANGING THE POSITION OF THE PATIENT, THE NURSE OBSERVED MASSIVE BLEEDING FROM THE ECMO CANNULA INSERTION SITE, LOCATED IN THE RIGHT JUGULAR REGION. THE CUSTOMER REPORTED THAT IT WAS DUE TO ACCIDENTAL REMOVAL OF THE DEVICE, RESULTING IN HEMODYNAMIC INSTABILITY. THE CUSTOMER HAS REPORTED THAT THE BLEEDING WAS CONTROLLED WITH DIRECT COMPRESSION, THEY THEN PROCEEDED TO PERFORM NEUROMUSCULAR BLOCKADE, SEDOANALGESIA ADJUSTMENT, RE-CANNULATED WITH ALL ECMO EQUIPMENT CIRCUIT AND MEMBRANE CHANGE. THE PATIENT WAS TRANSFUSED 2UGR AND 1 PLATELETPHERESIS, VASOACTIVE TITRATION AND SEDOANALGESIA. THE PATIENT STATUS IS CRITICALLY ILL PATIENT AND CONTINUING ECMO THERAPY AND VMI. ADDITIONAL INFORMATION: THE PATIENT HAD BEEN HOSPITALIZED IN ICU WITH PNEUMONIA SEVERE VIRUS DUE TO SARS-COV2, HYPOXEMIA, AND NEED FOR VENTILATION MECHANICAL, ON ECMO THERAPY SINCE (B)(6) 2021.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13044261 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924642. One submission often covers many models, so check the product and lot details in each record.

• Z-1928-2008 · May 9, 2008 · Terminated
  Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numbers: CB96345-023, CB96345-023, and CB96345-029.