Fortrex™ A35HPV06040080 (UDI 00763000634490)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000634490), received between Feb 10, 2025 and Sep 2, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50558288 ↗
• MalfunctionSep 2, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50558030 ↗
• MalfunctionNov 24, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A FORTEX BALLOON TO TREAT A LESION IN THE ILIAC ARTERY - COMMON. THE DEVICE WAS MISSING A MARKER POINT. A NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630499 ↗
• MalfunctionNov 12, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE FOR STENOSIS DILATION USING A FORTREX BALLOON CATHETER, BALLOON LEAKAGE AND BURST WERE OBSERVED DURING THE SECOND INFLATION AT A PRESSURE OF 22 ATM. THE PATIENT WAS TREATED FOR A FIBROUS LESION WITH NO TORTUOSITY OR CALCIFICATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534518 ↗
• MalfunctionAug 18, 2025Component Missing; Component Missing

  PHYSICIAN WAS ATTEMPTING TO USE FORTREX BALLOON TO TREAT PATIENT COMMON ILIAC ARTERY. IT WAS REPORTED THAT DEVICE WAS MISSING MARKER POINT. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825914 ↗
• MalfunctionJul 7, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT ARTERIOVENOUS FISTULA STENOSIS, THE FORTREX 06X040X80 BALLOON EXPERIENCED A LONGITUDINAL BALLOON BURST DURING INFLATION. A PRESSURE PUMP INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE EVENT OCCURRED DURING BALLOON INFLATION AT A PRESSURE OF 24 ATM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412476 ↗
• MalfunctionJul 4, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX 06X040X80 BALLOON, A PIN HOLE BURST WAS OBSERVED IN THE BALLOON DURING INFLATION AT 20 ATM. THE BALLOON LEAKED WAYER. THE PROCEDURE WAS BEING PERFORMED TO TREAT STENOSIS AT THE ANTERIOR WALL OF A PROSTHETIC VASCULAR GRAFT. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE.  ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A NEW BALLOON OF THE SAME SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402368 ↗
• MalfunctionJul 4, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING A FORTREX BALLOON. THE LESION WAS A PLAQUE LESION IN THE DISTAL REGION OF THE ARTERY. NO ISSUES NOTED WHEN THE DEVICE WAS REMOVED FROM PACKAGING. NO RESISTANCE DURING ADVANCEMENT. THE BALLOON WAS INFLATED USING A UNKNOWN PRESSURE PUMP. DURING BALLOON INFLATION A LONGITUDINAL BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 24 ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED BY OPENING A NEW BOX OF BALLOONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402361 ↗
• InjuryMar 7, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING A FORTREX 06X040X80 BALLOON, A NON-MEDTRONIC INFLATION DEVICE WAS USED AND THE BALLOON BURST CIRCUMFERENTIALLY/RADIALLY DURING INFLATION AT A PRESSURE OF 24 ATMS. THE EVENT OCCURRED AT AN ARTERIOVENOUS FISTULA (AVF) SITE. A WOUND WAS OPENED TO ASSIST IN REMOVING THE BALLOON, AND ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED USING A NEW HIGH-PRESSURE BALLOON FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21544815 ↗
• MalfunctionFeb 10, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE THE ARTERIOSCLEROSIS WAS SEVERE, AND A PIN HOLE BURST OCCURRED WHEN THE FORTREX 06X040X80 BALLOON WAS INFLATED TO 12 BARS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH A NEW ONE AND CONTINUING THE OPERATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342278 ↗