Fortrex™ A35HPV10080080 (UDI 00763000106379)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000106379), received between Sep 5, 2019 and Feb 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A FORTREX HIGH PRESSURE BALLOON AT THE LEFT AV FISTULA, THE BALLOON BURST ABOVE THE RATED BURST PRESSURE OF 20 ATM ON THE FIRST INFLATION. THE BURST WAS NOTED TO BE LONGITUDINAL, AND THE BALLOON DETACHED DURING THE EVENT. THE DOCTOR USED A SNARE TO REMOVE THE BALLOON FRAGMENTS FROM THE PATIENT, AND NO EVIDENCE OF THE BALLOON WAS SEEN UNDER FLUOROSCOPY. THE LESION WAS IDENTIFIED AS FIBROUS, LOCATED MID TO DISTAL IN THE LEFT AV FISTULA, WITH A LESION LENGTH OF 80 CM. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE WITH A 50/50 CONTRAST FLUID. THE PROCEDURE WAS COMPLETED AFTER THE DOCTOR SUCCESSFULLY REMOVED THE BALLOON FRAGMENTS USING THE SNARE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323939 ↗
• InjurySep 5, 2019Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A FORTREX BALLOON WITH A NON-MEDTRONIC 7 FR SHEATH FOR THE TREATMENT OF A NON-CALCIFIED, FIBROUS FISTULAE IN THE RIGHT ARM. THE LESION PRESENTED LITTLE TORTUOSITY AND 60% STENOSIS. ARTERY DIAMETER IS 10 CM. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED ON ADVANCEMENT. A MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT WAS REPORTED THAT A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED DURING INFLATION AT 18ATM. AN INCISION HAD TO BE PERFORMED ON THE FISTULAE TO RETRIEVE THE BALLOON FRAGMENTS FROM THE VASCULATURE. ALL BALLOON FRAGMENTS WERE REMOVED FROM THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT HAD HEMORRHAGE/BLEEDING IN THE ACCESS SITE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8964071 ↗