Bio-Medicus™ 96570-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169880795), received between Jun 30, 2023 and Dec 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS 21 FR FEMORAL ARTERIAL CANNULA THAT WAS USED TO ESTABLISH EXTRACORPOREAL CIRCULATION, IT WAS REPORTED THAT THE NURSE FOUND THAT THE STERILE PACKAGE WAS DAMAGED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE OUTER PACKAGING CARTON WAS NOT DAMAGED BUT THE INNER ASEPTIC PACKAGING WAS DAMAGED. THERE WERE NO OTHER DEVICES DAMAGED IN THE SAME BOX/SHIPPING CONTAINER. THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DID NOT OBSERVE THE DAMAGED PACKAGING PRIOR TO INSERTING THE CANNULA INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840887 ↗
• MalfunctionJul 6, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED THAT THEY ATTEMPTED TO PASS A GUIDE THROUGH THE INTRODUCER TO VERIFY THE LOCATION OF THE CANNULA, BUT IT DID NOT PASS. THE CUSTOMER THEN ATTEMPTED TO USE A HIGH SUPPORT GUIDE, HEMODYNAMIC GUIDE, BUT IT WAS NOT POSSIBLE FOR THEM TO PASS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17264902 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS BIO-MEDICUS CANNULA, DURING CANNULATION THE CANNULA WAS DIFFICULT TO ADVANCE, THE SURGEON ATTEMPTED TO REMOVE THE CANNULA AND FOUND THAT THE TIP WAS CORRUGATED. THE CANNULA WAS REPLACED WITH A BACK-UP. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION STATES THAT THE TIP WAS NOT OBSTRUCTED, AND DID NOT DETACH FROM CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED AND NO IMAGE IS AVAILABLE FOR THIS DEFECT. THE PROVIDED INFO WAS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262587 ↗
• MalfunctionJun 30, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED THAT THE SIZE OF THE CANNULA WALL AND THE INNER CORE WERE INCONSISTENT. IT WAS ALSO REPORTED THAT THE MODEL COULD NOT BE MATCHED DURING USE AND COULD NOT BE USED. THE CUSTOMER STATED THAT THE DIFFERENCE WAS NOTICED BEFORE INSERTION AND THEY WERE NOT SURE WHETHER IT COULD BE USED NORMALLY. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237091 ↗

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.