Fortrex™ A35HPV08080080 (UDI 00763000106225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000106225), received between Mar 3, 2021 and May 7, 2024 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Nonstandard Device; Device Markings/Labelling Problem; Nonstandard Device; Device Markings/Labelling Problem

  A PHYSICIAN USED A FORTREX HP PTA BALLOON WITH A 9FR SHEATH AND AN 035 NON-MEDTRONIC (BOSTON SUPERSTIFF AMPLATZ) GUIDEWIRE DURING A CHOLANGIOGRAPHY PROCEDURE OF THE PATIENTS BILIARY ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. 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 WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. EXCESSIVE FORCE WAS NOT USED. ACCORDING TO THE END-USER RECORD, A BALLOON WITH A DIAMETER SIZE OF 8MM WAS INTENDED TO BE UTILIZED BUT THERE SEEMS TO BE A DISCREPANCY BETWEEN THE SIZE INDICATED ON THE PACKAGE (8MM) AND THE ACTUAL SIZE (5MM) PERCEIVED DURING THE PROCEDURE. THE PHYSICIAN COMPARED THE 9F SHEATH (3.33MM) AND FORTREX EXPECTED SIZE (8MM X 80MM), THE BALLOON WAS FULLY INFLATED AT RATED BURST PRESSURE BUT ONLY SHOWED UP TO 5.13MM ON THE IMAGE. PHYSICIAN SUSPECTS IT IS A POTENTIAL MISLABELLING. THE PROCEDURE WAS COMPLETED USING THE 5MM BALLOON AND PATIENT WAS DISCHARGED. NO PATIENT INJURY RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258836 ↗
• MalfunctionApr 28, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED A FORTREX PTA BALLOON DURING PATIENT TREATMENT. 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. IFU WAS FOLLOWED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. CONTRAST WAS USED AS INFLATION FLUID. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. A BALLOON BURST IS REPORTED DURING INFLATION AT RBP DURING THE FIRST INFLATION. THE TYPE OF BURST IS UNKNOWN. THE BALLOON DID NOT FRAGMENT. NO VESSEL INJURY NOTED THE PROCEDURE WAS COMPLETED USING ANOTHER FORTREX BALLOON OF THE SAME SIZE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14236852 ↗
• InjuryMar 3, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE FORTREX PTA DURING PROCEDURE TO TREAT A LESION IN THE ARTERIOVENOUS FISTULA. INFLATION DEVICE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING THIRD INFLATION, BALLOON BURST/LEAK/CATHETER LEAK OCCURRED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 11403567 ↗