Fortrex A35HPV10040080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684057810), received between Jun 5, 2017 and Feb 28, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2019Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX BALLOON WITH AN NON-MEDTRONIC 7FR (TERUMO) SHEATH AND NON MEDTRONIC 0.035X180 STIFF ANGLED GUIDEWIRE TO TREAT A LESION IN A PATIENT IN THE DISTAL LEFT ARM FISTULA. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED PER THE IFU. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING INFLATION AT 18 ATMS, AND 4 INFLATIONS. REMOVAL DIFFICULTIES WERE ALSO EXPERIENCED REMOVING BALLOON FOLLOWING BALLOON INFLATION. DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. THE BALLOON WAS REMOVED WITH SHEATH AND REPLACED THE (TERUMO) SHEATH WITH 7F 23CM (CORDIALS) SHEATH TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377272 ↗
• MalfunctionNov 2, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO USE THE FORTREX BALLOON TO TREAT AN ARTERIOVENOUS FISTULA. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE, DURING BALLOON INFLATION THE BALLOON BURST AT RBT (RATED BURST PRESSURE). THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032360 ↗
• InjuryJun 5, 2017Burst Container or Vessel; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON IN THE RADIAL AV FISTULA. IT WAS REPORTED THAT WHEN PHYSICIAN TRIED TO REMOVE THE PTA FROM RADIAL ACCESS, THE BALLOON RUPTURED. THE RUPTURED PTA COULD NOT BE RETRIEVED THROUGH THE SHEATH. IT WAS REPORTED THAT THE PHYSICIAN WAS FORCED TO DO A CUT-DOWN TO RETRIEVE THE PTA BALLOON AND THE SHEATH. THE PATIENT WAS DISCHARGED AS SCHEDULED LATER IN THE DAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6611010 ↗