Fortrex™ A35HPV04020040Recalls & reported problems
Covidien LP · PTA A35HPV04020040 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 00763000105709), received between May 1, 2020 and May 1, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation 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.
Most reported problems
Device problems
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2020Inflation Problem; Inflation Problem
PHYSICIAN INTENDED TO USE A FORTREX HIGH PRESSURE BALLOON DURING TREATMENT OF AN ARTERIOVENOUS FISTULA (AVF). IFU WAS FOLLOWED. NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED THAT MULTIPLE INFLATIONS TO 18-20ATM WERE APPLIED TO THE DEVICE USING A NON-MEDTRONIC INFLATION DEVICE. ON THE SECOND OR THIRD INFLATION, THE PHYSICIAN NOTED THAT PRESSURE COULD NOT BE MAINTAINED BUT COULD IDENTIFY ANY LEAKS ON THE DEVICE. THE PHYSICIAN SUSPECTS A TEAR IN THE DEVICE BUT COULD NOT IDENTIFY WHERE THE LEAK WAS COMING FROM. THE PHYSICIAN COULD NOT SEE ANY CONTRAST LEAKING FROM THE HUB. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITHOUT ANY FRAGMENTS BEING LEFT IN THE PATIENT AS THE BALLOON WAS INTACT. A PACIFIC PLUS PTA BALLOON AND INPACT DRUG COATED BALLOON WERE THEN USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10016790 ↗
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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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