Fortrex™ A35HPV12080135 (UDI 00763000106447)Recalls & reported problems
Covidien LP · PTA A35HPV12080135 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 00763000106447), received between Aug 8, 2023 and Aug 8, 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.
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.
MalfunctionAug 8, 2023Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON FOR TREATMENT OF A SOFT TISSUE WITH MORE THAN 50% STENOSIS IN THE DISTAL LEFT COMMON ILIAC VEIN. THERE WAS MODERATE TORTUOSITY AND NO CALCIFICATION. PATIENT HAD MAY TURNER SYNDROME. THE PHYSICIAN WANTED TO USE THE 80MM LENGTH TO MINIMISE DISSECTION RISKS. A 9FR NON MEDTRONIC SHEATH. A 035 NITREX GUIDEWIRE WAS USED. A MEDTRONIC EVEREST DEVICE WAS USED FOR INFLATION. CONTRAST MIXED WITH SALINE WAS USED AS INFLATION FLUID. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING BALLOON INFLATION THE DEVICE BURST LONGITUDINALLY AT 10 ATM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS MET DURING ADVANCEMENT. AN ADMIRAL XTREME PTA BALLOON WAS OPENED TO PERFORM VENOPLASTY. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17479382 ↗
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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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