Fortrex™ A35HPV05080080Recalls & reported problems
Covidien LP · PTA A35HPV05080080 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 00763000105891), received between Feb 9, 2021 and Feb 9, 2021 — 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
- Entrapment of Device1
Patient problems
- Embolism/Embolus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2021Burst Container or Vessel; Entrapment of Device; Burst Container or Vessel; Entrapment of Device
PHYSICIAN USED A FORTREX HP BALLOON DURING AN ANGIOPLASTY PROCEDURE. IT IS REPORTED THE BALLOON WAS INFLATED TO RBP AND A RUPTURE OCCURRED. THE BALLOON IS REPORTED TO HAVE SHEARED. PARTIAL BALLOON EMBOLIZATION OCCURRED, AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE ENTIRE BALLOON FROM THE ACCESS. THE PATIENT WAS TAKEN TO A LOCAL HOSPITAL FOR SURGICAL INTERVENTION. NO FURTHER INJURY REPORTED.
Patient problems: Embolism/Embolus
MAUDE report 11300142 ↗
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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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