Bio-Medicus™ 96570-115 (UDI 00763000116071)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000116071), received between Feb 27, 2023 and Oct 21, 2025 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Crack; Crack

  IT WAS REPORTED THAT A CRACK MEASURING 1 INCH WAS IDENTIFIED ON THE CONNECTORS OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL/JUGULAR VENOUS CANNULAE DURING USE. THE DAMAGE WAS NOT LOCATED IN THE AREA OF THE SUTURES. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS ANY COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347166 ↗
• MalfunctionOct 21, 2025Crack; Crack

  IT WAS REPORTED THAT A CRACK MEASURING 1 INCH WAS IDENTIFIED ON THE CONNECTORS OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL/JUGULAR VENOUS CANNULAE DURING USE. THE DAMAGE WAS NOT LOCATED IN THE AREA OF THE SUTURES. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS ANY COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347113 ↗
• DeathMar 19, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF A BIO-MEDICUS CANNULA, THERE WAS A SUDDEN BREAK AT THE LATERAL BRANCH CIRCULATION. THE USE OF THE DEVICE WAS UNSPECIFIED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

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

  MAUDE report 21641315 ↗
• MalfunctionFeb 10, 2025Crack; Crack

  IT WAS REPORTED THAT DURING SURGERY THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA WAS FOUND TO BE DAMAGED UPON UNPACKING. 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 21342098 ↗
• MalfunctionJan 30, 2024Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT WHILE PERFORMING CARDIAC SURGERY TO ESTABLISH PERIPHERAL SYSTEMIC CIRCULATION, THEY DISCOVERED A CRACK AT THE TIP END OF THE TUBE BODY WHEN USING THE DEVICE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE CUSTOMER STATED THAT THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605296 ↗
• MalfunctionJan 12, 2024Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, THE CUSTOMER R EPORTED THAT WHILE THE DEVICE WAS BEING PLACED THEY NOTICED THAT UPON OPENING THAT THERE WAS A FISSURE IN THE DISTAL PART. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER OBSERVED THE ISSUE PRIOR TO INSERTION SO THEY REPLACED THE PRODUCT AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501076 ↗
• MalfunctionFeb 27, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT THE DEVICE HAD A CRACK AT THE INTERFACE. USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442453 ↗