Bio-Medicus™ 96570-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000116101), received between Jan 19, 2023 and Jun 9, 2025 — classified as 4 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 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.

• MalfunctionJun 9, 2025Contamination; Contamination

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL/JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT THERE WAS A FOREIGN MATERIAL WITHIN THE PACKAGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167824 ↗
• MalfunctionJul 5, 2024Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THE CANNULA CLAMP AREA WAS DAMAGED AND THE INTERNAL GUIDE DEVICE WAS FLAT. THE CUSTOMER WAS WORRIED ABOUT THE RISK OF USING IT, SO IT WAS DISCARDED IMMEDIATELY.THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678854 ↗
• MalfunctionMar 15, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULARVENOUS CANNULA, IT WAS REPORTED THAT WHEN PREPARING FOR INSERTION OF THE DEVICE, A CRACK WAS DISCOVERED ON THE CONNECTOR OF THE CANNULA. THERE HAD BEEN NO EXTERNAL IMPACT ON THE CANNULA AND THE CRACK WAS DETECTED BEFORE INSERTION INTO THE PATIENT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO PATIENT BLOOD LOSS OR TRANSFUSION REQUIRED AS THE CRACK WAS DETECTED BEFORE INSERTION INTO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544210 ↗
• MalfunctionJan 19, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT WHEN THEY OPENED THE DEVICE PACKAGE THEY OBSERVED A CRACK IN THE CONNECTOR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO DAMAGE WAS OBSERVED TO THE PACKAGING AND THE STERILE BARRIER WAS NOT COMPROMISED. THE HEMOSTASIS CAP WAS NOT USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16202326 ↗