Fortrex A35HPV12080080Recalls & reported problems
Covidien LP · 0.035 OTW PTA Balloon Catheter · Class 2
All models of Fortrex (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684057902), received between May 16, 2017 and May 16, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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
Device problems
- Burst Container or Vessel1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2017Burst Container or Vessel; Burst Container or Vessel
THE PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON TO OPEN UP AN ILIAC STENT. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND PREPPED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE BALLOON BURST AT 7ATM PRESSURE. THE BALLOON WAS RETRIEVED IN FULL AND NO PATIENT INJURY WAS REPORTED. IT WAS REPORTED THAT THE STENT STRUT CAUSED THE BALLOON TO BURST. THE PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY WITH NO INTERVENTION NEEDED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6571319 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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