Fortrex™ A35HPV09040080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000106287), received between Mar 15, 2021 and Jul 17, 2024 — 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.

• MalfunctionJul 17, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING TREATMENT OF A PLAQUE LESION IN THE PATIENTS MID RADIAL ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. A PIN HOLE BALLOON BURST AT UNKNOWN PRESSURE WAS REPORTED DURING THE PROCEDURE. ISSUE OCCURRED ON FIRST INFLATION. THE BALLOON DID NOT DETACH DURING EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759683 ↗
• MalfunctionMar 15, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX BALLOON PTA DEVICE TO TREAT A LESION IN THE LEFT SUBCLAVIAN IN A PATIENT WITH 40% STENOSIS. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION AT 16ATMS. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483383 ↗