Fortrex™ A35HPV06100080 (UDI 00763000106041)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000106041), received between Aug 11, 2021 and Jan 3, 2024 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A ELLIPSYS CATHETER WAS USED TO TREAT A LESION LOCATED IN THE LEFT ARM AND TWO FORTREX BALLOONS DURING THE SECONDARY PROCEDURE. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED A CLOTTED AV FISTULA. THE PATIENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18433841 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A ELLIPSYS CATHETER WAS USED TO TREAT A LESION LOCATED IN THE LEFT ARM AND TWO FORTREX BALLOONS DURING THE SECONDARY PROCEDURE. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED A CLOTTED AV FISTULA. THE PATIENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18433837 ↗
• MalfunctionDec 14, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN ATTEMPTED TO USE AN FORTREX HP PTA BALLOON CATHETER DURING PATIENT TREATMENT. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED BALLOON INFLATION DIFFICULTIES OCCURRED WHEN DEVICE WAS INFLATED TO NOMINAL BURST PRESSURE. THERE WAS NO LEAK NOTED IN THE DEVICE. THE BALLOON DID NOT BURST. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NEW FORTREX DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003890 ↗
• MalfunctionAug 11, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL CENTRAL VENOUS FISTULA WITH 70% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE BALLOON BURST LONGITUDINALLY DURING ONE INFLATION AT 10 ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306704 ↗