Fortrex™ A35HPV06080135 (UDI 00763000106027)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000106027), received between Aug 2, 2022 and Jul 2, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE FORTREX BALLOON TREATMENT OF FIBROUS LESION IN PATIENTS RIGHT MID ARTERY/VEIN. MODERATE CALCIFICATION AND LITTLE TORTUOSITY WERE REPORTED. ARTERY DIAMETER REPORTED AS 4-6MM AND LESION DIAMETER REPORTED AS 60-80MM. EMBOLIC PROTECTION WAS USED AND INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED AND IT WAS NOTED THAT PRESSURE WAS AT 20ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE BALLOON WAS REPLACED WITH A SMALLER ONE, BLOCKED THE BLOOD FLOW, AND CHANGED TO OPEN SURGERY FOR THROMBECTOMY AND DILATION. NO FUTHER PATIENT INJURY REPROTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384951 ↗
• MalfunctionAug 2, 2022Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A FORTREX PTA BALLOON CATHETER DURING TREATMENT OF A PATIENT¿S ARTERIOVENOUS FISTULA (AVF). AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THE THE OUTER PACKAGING OF THE BALLOON WAS INTACT DURING PREOPERATIVE CHECK. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. AFTER THE BALLOON WAS OPENED TO EXTRACT THE SALINE DURING THE OPERATION, IT WAS FOUND THAT THE PRESSURE OF THE BALLOON COULD NOT BE PRESSED UP. AFTER CAREFUL INSPECTION, IT WAS FOUND THAT THE BALLOON WAS LEAKY AND LIQUID WAS FLOWING OUT. IT IS REPORTED A PINHOLE BALLOON LEAK WITHIN THE WORKING PRESSURE RANGE WAS NOTED DURING BALLOON INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. IT WAS REPLACED WITH A NEW BALLOON IMMEDIATELY AFTER THE PROBLEM WAS FOUND TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147920 ↗