Fortrex™ A35HPV10080135Recalls & reported problems
Covidien LP · PTA A35HPV10080135 FORTREX V02 · Class 2
All models of Fortrex (34)
Data updated Oct 18, 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 00763000106386), received between May 2, 2023 and May 2, 2023 — 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 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2023Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS USING A FORTREX PTA BALLOON DURING A VENOPLASTY PROCEDURE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDEN TIFIED. THE BALLOON WAS INFLATED USING A SYRINGE AND VISIPAQUE CONTRAST MEDIA INFLATION FLUID. IT WAS REPORTED DURING THE SECOND INFLATION THE BALLOON BURST AT AN UNKNOWN ATM. ALL FRAGMENTS WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS MET WHILE ADVANCING. NO PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16853428 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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