Fortrex™ A35HPV08100080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000106256), received between Aug 26, 2019 and Dec 11, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER WITH A 7FR SHEATH DURING PATIENT TREATMENT. 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. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO EMBOLIC PROTECTION DEVICE WAS USED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A BALLOON BURST DURING BALLOON INFLATION WAS REPORTED. ISSUE OCCURRED ON FIRST INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. A REPLACEMENT FORTREX BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299978 ↗
• InjurySep 8, 2023Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  A PHYSICIAN WAS USING A FORTREX PTA BALLOON DURING TREATMENT OF DIALYSIS FISTULAE GRAFT. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING THE PROCEDURE STRETCHING OCCURRED ON THE SHAFT OF THE DEVICE. THERE WAS DIFFICULTY REMOVING THE BALLOON FOLLOWING BALLOON INFLATION. A CUT-DOWN ON THE ARM AND VESSEL WAS NEEDED TO RETRIEVE THE BALLOON DISTAL TIP.

  Patient problems: Insufficient Information

  MAUDE report 17709522 ↗
• MalfunctionMay 17, 2023Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS USED A FORTREX PTA BALLOON DURING TREATMENT OF THE CENTRAL VEIN. THE PATIENT'S CENTRAL VEIN WAS STENOTIC. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE BALLOON BURST LONGITUDINALLY AT 9ATM. ALL FRAGMENTS WERE RETRIEVED. THE BALLOON HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE. A NEW BALLOON WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946969 ↗
• MalfunctionSep 14, 2022Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE A FORTEX PTA BALLOON CATHETER FOR TREATMENT OF A 100MM SOFT TISSUE LESION IN THE LEFT MID REGION OF THE LEFT AXILLARY VEIN. THERE WAS NO TORTUOSITY OR CALCIFICATION. THE IFU WAS FOLLOWED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING INFLATION THERE WAS BALLOON BURST. ALL FRAGMENTS WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN USED A DIFFERENT BALLOON TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416430 ↗
• MalfunctionMay 26, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX BALLOON TO TREAT A LESION IN THE PATIENT¿S FISTULA. NO DAMAGE WAS NOTED TO PACKAGING, DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT THE DURING BALLOON INFLATION, THE BALLOON BURST LOWER THE RECOMMENDED RATE. THE BALLOON DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED, AND NO EXCESSIVE FORCE WAS USED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO COMPLICATIONS OCCURRED DUE TO THIS EVENT. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14510177 ↗
• InjuryJun 3, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  THE PHYSICIAN USED A FORTREX BALLOON TO TREAT A SOFT TISSUE LESION IN THE MID LEFT AXILLARY VEIN. DEGREE OF TORTUOSITY WAS REPORTED AS LITTLE WITH NO CALCIFICATION AND 60% STENOSIS. THE ARTERY DIAMETER WAS 8M AND LESION WAS 80MM IN LENGTH. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THE BALLOON WAS INFLATED WITH A NON MEDTRONIC INFLATION DEVICE. CONTRAST AND SALINE WERE USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT DURING INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED. INFLATION PRESSURE APPLIED TO THE BALLOON PRIOR TO THE RUPTURE/BURST/LEAK WAS 20 ATMS. MOST BUT NOT ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED, SOME DETACHED PORTIONS OF DEVICE REMAIN IN PATIENT. A STENT WAS PLACED AT THE SITE WHERE BALLOON FRAGMENTS WERE LEFT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER PATIENT INJURY RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10114889 ↗
• MalfunctionAug 26, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING AN ATTEMPT TO USED FORTREX, IT WAS REPORTED THAT THE BALLOON BURST. ALL FRAGMENT OF BALLOON WERE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8929723 ↗