Bio-Medicus™ 96570-117 (UDI 00763000116088)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000116088), received between Jun 14, 2022 and Jan 21, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA AND KITS, IT WAS REPORTED THAT THE PACKAGING WAS WORN. THE DEVICE WAS REPLACED. THERE WAS NO CONSEQUENCE TO THE PATIENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DAMAGE/ABNORMAL APPEARANCE WAS LOCATED ON THE OUTER PACKAGE. THE DAMAGE APPEARED AS A RIP. THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS NOT INTACT. THE DEVICE WAS SEALED/LOCATED IN THE 'SEAL'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134515 ↗
• MalfunctionJun 12, 2025Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA AND KIT, IT WAS REPORTED THAT WHEN THE PACKAGE WAS UNPACKED A CRACK WAS FOUND AT THE INTERFACE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191918 ↗
• MalfunctionMay 6, 2025Contamination; Contamination

  IT WAS REPORTED PRIOR TO USE OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, BIOLOGICAL REMAINS WERE OBSERVED ON THE RETURNED DEVICE. THE CANNULA WAS RETURNED FROM THE CENTER TO THE WAREHOUSE. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966970 ↗
• MalfunctionNov 5, 2024Misassembled During Installation; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT THE OUTSIDE PACKAGE WAS THE BIO-MEDICUS NG ARTERY BUT THE INSIDE DEVICE WAS THE BIO-MEDICUS NG VENOUS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608209 ↗
• MalfunctionSep 26, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT THE CANNULA WAS KINKED. IT WAS OBSERVED WHEN THE CANNULA WAS OPENED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309344 ↗
• MalfunctionJul 18, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT DURING INSERTION THE CUSTOMER HEARD A CRACK. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. 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 19769490 ↗
• MalfunctionJul 5, 2024Crack; Misassembled During Installation; Crack; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED AND IT WAS READY TO INSERT THE CANNULA, IT WAS FOUND THAT THERE WAS DAMAGE NEAR THE HEMOSTATIC CAP. THE CUSTOMER WAS WORRIED THAT THE CANNULA WAS DAMAGED, SO IT WAS NOT CONTINUED TO BE USED IT AND IT WAS DISCARDED DIRECTLY.THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678152 ↗
• MalfunctionJun 20, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT THE DEVICE CRACKED UNDER THE VENTED STANDARD 3/8-INCH CONNECTOR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19573384 ↗
• MalfunctionDec 14, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, IT WAS REPORTED THAT IT WAS DAMAGED. USE OF THE DEVICE WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325532 ↗
• MalfunctionSep 29, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT THERE WAS DEFORMATION (A BURR) NOTED ON THE CANNULA BODY, NEAR THE TIP. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842160 ↗
• MalfunctionJun 14, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, IT WAS REPORTED THAT THE CONNECTION CRACKED. USE OF THE CANNULA WAS UNSPECIFIED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. INFORMATION ON WHETHER BLOOD WAS LOST BECAUSE OF THE CRACK AND IF A TRANSFUSION WAS REQUIRED WERE REQUESTED BUT THE CUSTOMER DID NOT PROVIDE THE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685979 ↗