Bio-Medicus™ 96551Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20763000115986), received between May 15, 2023 and Mar 18, 2026 — classified as 4 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 13, 2021Open, Classified

   There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

   Z-0003-2022 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionMar 18, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN INSERTION KIT, IT WAS REPORTED THAT WHILE PERFORMING ECMO (E XTRACORPOREAL MEMBRANE OXYGENATION) CANNULATION FOR THE PATIENT, CUSTOMER OPENED THE ARTERIOVENOUS CANNULA FOR PUNCTURE, AND FOUND THAT THE GUIDEWIRE COULD NOT PASS THROUGH. THE DILATOR TIP WAS ALSO NOT FULLY OPEN. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628396 ↗
• MalfunctionMar 12, 2026Material Deformation

  IT WAS REPORTED THAT A SOLID DILATOR WAS FOUND AMONG THE BIO-MEDICUS NEXTGEN INSERTION KIT PRIOR TO THE PROCEDURE, AND A DEFECTIVE PRODUCT WAS REPORTED. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577748 ↗
• MalfunctionNov 14, 2023Material Puncture/Hole; Air/Gas in Device; Material Puncture/Hole; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN INSERTION KIT, THE CUSTOMER REPORTED THAT WHILE THEY WERE ATTEMPTING TO USE THE SELDINGER NEEDLE, IT CRACKED AT THE HUB OR BASE OF THE NEEDLE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE NEEDLE CRACKED AT THE HUB. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER PUT THE SYRINGE ON THE NEEDLE AND PROCEEDED TO DO THE VENOUS PUNCTURE AND KEPT GETTING AIR IN THE SYRINGE. THE NEEDLE CAME OUT OF THE PACKAGE CRACKED AT THE HUB. THE CUSTOMER REPORTED THAT THE NEEDLE WAS ALREADY BROKEN OUT OF THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130055 ↗
• MalfunctionMay 15, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THE CUSTOMER REPORTED WHEN THEY OPENED THE BIO-MEDICUS NEXTGEN INSERTION KIT THEY FOUND THE GUIDEWIRE WAS FOLDED/BENT. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929588 ↗