Fortrex™ A35HPV08080135Recalls & reported problems
Covidien LP · PTA A35HPV08080135 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000106232), received between Sep 6, 2022 and Sep 6, 2022 — classified as 1 injury.
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
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2022Burst Container or Vessel; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Burst Container or Vessel; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BALLOON WAS TORN CROSSWISE WITH NO POSSIBILITY TO RETRIEVE IT.
Patient problems: Insufficient Information
MAUDE report 15362970 ↗
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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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