Bio-Medicus™ 96670-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000060619), received between Feb 5, 2025 and Sep 14, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Misassembled During Installation

  Medtronic received information that prior to use of a Bio-Medicus NextGen femoral Bi-Caval venous cannula, it was reported that the outer packaging box for the product is labeled 96670-121, but the cannula inside bears the model number 96570-121. See attached photo. The device was replaced. There was no patient involvement, so no adverse effect occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755797 ↗
• MalfunctionNov 13, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA AND KIT, AFTER WIRE POSITIONING, THE MAIN BODY OF THE CANNULA BECAME STUCK HALFWAY DURING ADVANCEMENT OVER THE WIRE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. CANNULATION WAS SUCCESSFULLY COMPLETED BY ADVANCING IT OVER THE SAME WIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541753 ↗
• MalfunctionOct 29, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA AND KIT, THE INTRODUCER COULD NOT BE WITHDRAWN AFTER POSITIONING, WHICH MADE IT IMPOSSIBLE TO CONNECT WITH THE TUBING PACK DUE TO INTRODUCER MALFUNCTION. A NEW INTRODUCER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412553 ↗
• MalfunctionMar 18, 2025Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA, IT WAS REPORTED THAT THE TIP OF THE CANNULA WAS OBSERVED TO BE CRACKED WHEN UNPACKING AND PREPARING TO FLUSH THE DEVICE. THE DEVICE WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. T HERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632519 ↗
• MalfunctionFeb 5, 2025Crack; Crack

  IT WAS REPORTED THAT THE INTERFACE OF THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA WAS FOUND TO BE DAMAGED AS SOON AS IT WAS OPENED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312509 ↗