Fortrex A35HPV07040080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684057575), received between Nov 17, 2017 and Dec 6, 2017 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON CATHETER TO TREAT A 30MM SEVERELY CALCIFIED FIBROUS LESION IN THE LEFT PROXIMAL BRACHIAL ARTERY. THE ARTERY WAS 7MM IN DIAMETER, HAD MODERATE TORTUOSITY AND HAD 80% STENOSIS. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.035" NON-MEDTRONIC GUIDEWIRE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NO PRE-DILATION OF THE VESSEL WAS PERFORMED. THE PHYSICIAN ENCOUNTERED NO RESISTANCE DURING THE ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE BALLOON WAS INFLATED USING A MEDTRONIC AC3205P INFLATION DEVICE WITH CONTRAST FLUID. IT WAS REPORTED THAT DURING THE FIRST INFLATION, THE BALLOON BURST LONGITUDINALLY AT 20ATMS, AFTER 55 SECONDS. THE BALLOON MATERIAL WAS REPORTED TO REMAIN INTACT AND NO FRAGMENTS WERE MISSING. ANOTHER FORTREX BALLOON CATEHTER WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089962 ↗
• MalfunctionNov 17, 2017Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN EMPLOYED THE USE OF A 7 MM FORTREX PTA BALLOON CATHETER AND A MDT INFLATION DEVICE FOR A FISTULOPLASTY PROCEDURE. A 6 FR NON-MEDTRONIC SHEATH WAS USED. EMBOLIC PROTECTION WAS NOT USED. IFU WAS FOLLOWED. THIS DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NORMAL VESSEL SIZE WAS 8 MM, TARGET LESION NARROWED TO 3 MM. A 4 MM FORTREX BALLOON HAD ALREADY BEEN USED ON THE LESION PRIOR TO THIS 7 MM FORTREX BALLOON. IT WAS REPORTED THAT THE 7 MM FORTREX BALLOON BURST DURING THE PROCEDURE (BURST OCCURRED DURING GRADUAL INFLATION AT A PRESSURE OF 16 ATM). THE BALLOON DID NOT BREAK INTO FRAGMENTS AND WAS REMOVED INTACT WHEN PULLING OUT THE CATHETER. THE PHYSICIAN POST-DILATED THE LESION USING A SIZE 6 MM IN. PACT ADMIRAL BALLOON. NO PATIENT INJURY WAS REPORTED. PATIENT IS REPORTED AS BEING STABLE. THERE WERE NO INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7040021 ↗