Fortrex A35HPV08040080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684057667), received between Nov 16, 2018 and Mar 20, 2020 — classified as 3 injuries.

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.

• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A MEDTRONIC PTA BALLOON WAS USED TO TREAT THE VENOUS OUTFLOW IN THE LEFT ARM. APPROXIMATELY 23 MONTHS POST PROCEDURE, PATIENT SUFFERED STENOSIS IN THE AVF WHICH WAS TREATED USING A NON-MEDTRONIC PTA BALLOON. PATIENT RECOVERED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 9858976 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, ONE FORTEX OTW PTA BALLOON CATHETER WAS USED TO TREAT A LESION LOCATED IN THE VENOUS OUTFLOW OF THE LEFT ARM. APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ELEVATED VELOCITIES TO THE TARGET AVF. EVENT WAS TREATED WITH NON-MEDTRONIC PTA IN THE VENOUS OUTFLOW (TARGET VESSEL). INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, PROCEDURE OR PACLITAXEL. PATIENT RECOVERED.

  Patient problems: Injury

  MAUDE report 9086849 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ((B)(6) 2018), ONE MEDTRONIC STANDARD PTA DEVICE WAS USED TO TREAT A LESION LOCATED IN THE VENOUS OUTFLOW OF THE LEFT ARM. APPROXIMATELY 2 MONTHS ((B)(6) 2018) POST INDEX PROCEDURE, PATIENT SUFFERED AN ANEURYSM IN THE AREA OF THE FISTULA. EVENT WAS TREATED WITH A SURGICAL INTERVENTION OF THE VENOUS OUTFLOW. INVESTIGATOR ASSESSED THAT THE EVENT IS NOT RELATED TO INDEX DEVICE, PROCEDURE OR ANTIPLATELETS MEDICATION. OUTCOME OF THE EVENT IS UNKNOWN. NON MEDTRONIC DEVICE WAS USED FOR PREDILATION AND A MEDTRONIC FORTREX BALLOON WAS USED AS THE TREATMENT DEVICE DURING THE INDEX PROCEDURE [PVEV NOTIFIED OF FORTREX DEVICE].

  Patient problems: Occlusion

  MAUDE report 8078310 ↗