Bio-Medicus™ 96570-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169880788), received between Jun 30, 2023 and Dec 11, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS ONE PIECE FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT THE HOLE IN FRONT OF THE INTRODUCER WAS BLOCKED, PREVENTING THE GUIDE WIRE FROM PASSING THROUGH. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901439 ↗
• MalfunctionApr 25, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE PIECE FEMORAL ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT UPON CANNULATION, THE INTRODUCER WOULD NOT ALLOW THE GUIDEWIRE TO PASS THROUGH. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THE INITIAL INSERTION SITE WAS USED WHEN THE CANNULA WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179290 ↗
• MalfunctionJun 30, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN CANNULA, THE CUSTOMER REPORTED THAT THE TIP OF THE INTRODUCER WAS ¿OFFSET¿. THE CANNULA WAS DISCARDED, THE INTRODUCER WAS SAVED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. ADDITIONAL INFORMATION: THERE WAS NO DAMAGE TO THE PACKAGING. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237067 ↗

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.