Fortrex™ A35HPV08040080 (UDI 00763000634704)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000634704), received between Dec 2, 2025 and Sep 30, 2026 — classified as 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Leak/Splash

  It was reported that intra-operatively, during inflation, the luer of a Fortrex PTA balloon catheter device was noted to be leaking. No damage was noted to the packaging and no issues were noted when removing the device from the tray/hoop. The device was prepped per IFU, with no issues identified. A new device was used to complete the procedure. No patient complications have been reported as a result of this event. Additional information: Based on review of the images the leak was coming from the shaft.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942834 ↗
• MalfunctionDec 14, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING BALLOON INFLATION WITH THE FORTREX, LONGITUDINAL BURST OCCURRED AT THE BALLOON. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED. THE EVENT WAS OBSERVED AT AN INFLATION PRESSURE OF 20RBP. NO RESISTANCE WAS E NCOUNTERED WHEN ADVANCING THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. THE PROCEDURE WAS COMPLETED BY REMOVING THE WHOLE SYSTEM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799504 ↗
• MalfunctionDec 2, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT DURING THE USE OF THE FORTREX 08X040X80 BALLOON FOR A PROCEDURE, A BALLOON BURST, BALLOON LEAK OR CATHETER LEAK OCCURRED DURING THE FIRST INFLATION AT A PRESSURE OF 10 ATM. NO ISSUES WERE IDENTIFIED DURING PREPARATION OR REMOVAL FROM THE PACKAGING. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER FORTREX BALLOON. THERE WAS NO HARM OR INJURY TO THE PATIENT AS A RESULT OF THE EVENT AND NO INTERVENTION REQUIRED TO RETRIEVE THE BALLOON FRAGMENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694744 ↗