Fortrex™ A35HPV07080080Recalls & reported problems
Covidien LP · PTA A35HPV07080080 FORTREX V02 · 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 00763000106133), received between Dec 18, 2023 and Dec 18, 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 16, 2026.
Reports received per month
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.
MalfunctionDec 18, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A FORTREX BALLOON TO TREAT A LESION. A 7FR SHEATHE WAS USED. AN INFLATION DEVICE WAS USED. SALINE WAS USED FOR INFLATION FLUID. DEVICE WAS PREPPED PER IFU. THE BALLOON BURST AFTER ONE INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. ANOTHER BALLOON WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18345509 ↗
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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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