Fortrex™ A35HPV06040135 (UDI 00763000634506)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000634506), received between Feb 24, 2025 and Nov 11, 2025 — 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.

• MalfunctionNov 11, 2025Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE 035 HPV BALLOON, THERE WAS DIFFICULTY REMOVING THE BALLOON FOLLOWING BALLOON INFLATION. THE PROCEDURE WAS PERFORMED IN THE PROXIMAL SEGMENT OF THE LEFT CEPHALIC VEIN, TARGETING A FIBROUS LESION WITH MODERATE TORTUOSITY AND NO CALCIFICATION, USING A 6FR SHEATH AND A .035 TERUMO GUIDEWIRE. THE BALLOON WAS INFLATED WITH A BOSTON INFLATION DEVICE. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. AFTER ANGIOPLASTY, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO INSERT THE DEVICE AGAIN, SO A BALLOON OF THE SAME SIZE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION 2025-OCT-30: THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT THROUGH THE SHEATH. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523355 ↗
• MalfunctionJul 8, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION (100% STENOSIS) OF A MODERATELY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY, A BALLOON BURST OCCURRED DURING INFLATION WITH THE FORTREX BALLOON DEVICE. ALL BALLOON FRAGMENTS WERE RETRIEVED, AND THERE WERE NO ABNORMALITIES IN ANATOMY OR PROCEDURAL COMPLICATIONS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. SUBSEQUENTLY, A BALLOON BURST ALSO OCCURRED DURING INFLATION WITH THE CATHETER PACIFIC PLUS BALLOON DEVICE. ALL BALLOON FRAGMENTS WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR BALLOON. NO PATIENT SYMPTOMS, COMPLICATIONS, INJURIES, INFECTIONS, ADVERSE OUTCOMES, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434510 ↗
• MalfunctionFeb 24, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON DURING A PROCEDURE. A BALLOON BURST AT AN UNKNOWN PRESSURE WAS REPORTED. THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446647 ↗