Fortrex™ A35HPV08040135Recalls & reported problems
Covidien LP · PTA A35HPV08040135 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 00763000106201), received between May 27, 2024 and May 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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
- Device Markings/Labelling Problem1
- Nonstandard Device1
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 27, 2024Nonstandard Device; Device Markings/Labelling Problem; Nonstandard Device; Device Markings/Labelling Problem
A PHYSICIAN USED A FORTREX HP PTA BALLOON WITH A 6FR SHEATH AND AN 035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF THE PATIENTS BILIARY ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. A NON-MEDTRONIC INFLATION DEVICE WAS USED, CONNECTED AS PER IFU WITH A 50% CONTRAST 50% SALINE USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED AN 8MM BALLOON WAS UTILIZED, BUT THERE SEEMED TO BE A DISCREPANCY BETWEEN THE SIZE INDICATED AND THE ACTUAL SIZE PERCEIVED (6MM). PHYSICIAN INFLATED BALLOON UP TO 20ATM BUT STILL DID NOT REACH THE SIZE OF 8MM. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. PATIENT ALREADY DISCHARGED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19401008 ↗
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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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