Fortrex™ A35HPV05040080 (UDI 00763000105860)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000105860), received between Mar 22, 2021 and Jul 8, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX 05X040X80 DILATION BALLOON, THE PATIENT WAS BEING TREATED FOR A PLAQUE LESION WITH LITTLE TORTUOSITY AND CALCIFICATION IN THE DISTAL LEFT ARTERY. DURING THE SURGERY, WHEN THE BALLOON WAS DILATED TO 20PA, IT RUPTURED AND A LARGE AMOUNT OF BLOOD ENTERED THE PRESSURE PUMP. THE BALLOON WAS DIRECTLY REMOVED, AND THE PROCEDURE WAS COMPLETED AFTER REPLACING THE BALLOON WITH ANOTHER OF THE SAME MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434605 ↗
• MalfunctionJun 16, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX 05 X 040 X 80 BALLOON, A PATIENT WITH PERIPHERAL ANASTOMOTIC STENOSIS AND A CALCIFIED TARGET LESION EXPERIENCED A PIN HOLE BALLOON BURST DURING BALLOON INFLATION AT 20 ATMOSPHERES. LITTLE VESSEL TORTUOSITY AND LITTLE VESSEL CALCIFICATION WERE REPORTED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209984 ↗
• InjuryFeb 2, 2022Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE THE FORTREX PTA BALLOON CATHETER DURING PROCEDURE. A 6FR SHEATH AND 1.5M GUIDEWIRE WERE USED. INFLATION DEVICE WAS USED TO INFLATE BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT THERE WERE REMOVAL DIFFICULTIES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO ABNORMALITIES FOUND WHEN DEFLATING DEVICE. BALLOON WAS NOT PRESSURIZED TO 24ATM, RUPTURED OCCURRED AT 20ATM. OPEN SURGICAL REMOVAL REQUIRED TO REMOVE DEVICE. MINOR VESSEL DAMAGE NOTED. DEVICE WAS SAFELY REMOVED. THE PROCEDURE WAS COMPLETED BY OPENING THE BALLOON AND DISPOSING OF IT SEPARATELY. NO PATIENT INJURY. PATIENT IS IN GOOD CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 13421489 ↗
• MalfunctionSep 2, 2021Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A FORTREX PTA BALLOON DURING PATIENT TREATMENT FOR THE FOREARM CEPHALIC VEIN OF THE ARM'S AUTOGENOUS ARTE RIOVENOUS FISTULA. THERE WAS VESSEL STENOSIS LESION OF THE CEPHALIC VEIN. IFU WAS FOLLOWED. PRIOR TO USE, IODOPHOR WAS USED FOR SKIN DISINFECTION. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT. THE BALLOON WAS DELIVERED INTO THE STENOSIS IN THE BLOOD VESSEL THROUGH THE GUIDEWIRE. THE BALLOON COULD NOT BE INFLATED AFTER IT WAS CONNECTED TO THE PRESSURE PUMP. THE DEVICE WAS REMOVED SAFELY FROM THE PATIENT IT WAS NOTED THERE WAS A LEAK ON THE BALLOON CATHETER WHEN ATTEMPTING TO INFLATE. THE DEVICE WAS REPLACED WITH A BALLOON OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12412257 ↗
• MalfunctionMay 6, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED A FORTREX HP PTA BALLOON DURING A LEFT FOREARM ARTERIOVENOUS FISTULA INTERVENTION. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT THE BALLOON BURST DURING USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782664 ↗
• MalfunctionMar 22, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED A FORTREX HP BALLOON DURING TREATMENT OF RENAL ARTERY STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A BALLOON BURST DURING THE PROCEDURE IS REPORTED. THE PROCEDURE WAS COMPLETED WITH BALLOON DILATION TREATMENT. THERE WAS NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11540493 ↗