Fortrex™ A35HPV07040135Recalls & reported problems
Covidien LP · PTA A35HPV07040135 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 00763000106119), received between Oct 24, 2019 and Oct 24, 2019 — 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
- Leak/Splash1
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.
MalfunctionOct 24, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash
PHYSICIAN INTENDED TO USE A FORTREX HP PTA BALLOON WITH A 6FR SHEATH AND 0.014 X 300 CM NITREX WIRE DURING TREATMENT OF A 30MM PLAQUE LESION IN THE PATIENT¿S MID AND PROXIMAL RIGHT COMMON ILIAC ARTERY OF DIAMETER 7-8MM. SLIGHT CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 60% STENOSIS. A STEEP AORTIC BIFURCATION IS ALSO REPORTED. PROTÉGÉ GPS WAS DEPLOYED WITHOUT ISSUE PRIOR TO USE OF THE FORTREX. IFU WAS FOLLOWED. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE FORTREX. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. DEVICE PREPPED WITHOUT ISSUE. NEGATIVE PREP WAS NOT PERFORMED. NO LEAKS WERE NOTED FROM BALLOON/PORTS DURING PREP. THE PHYSICIAN ATTEMPTED TO ADVANCE THE FORTREX BALLOON CATHETER THROUGH THE EXISTING SHEATH IN ATTEMPT TO CROSS THE LESION FOR TREATMENT, RESISTANCE WAS FELT AS THE BALLOON WOULD NOT CROSS THE LESION RESULTING IN THE SHEATH BACKING UP OUT OF ITS ORIGINAL DESIRED POSITION THEREFORE COULD NOT PROVIDE SUPPORT FOR BALLOON CROSS. THE 014 WIRE WAS EXCHANGED FOR A 035 NON-MEDTRONIC WIRE THROUGH PTA. MULTIPLE ATTEMPTS TO ACCESS CONTRALATERAL SIDE THEN SUCCESSFUL. THE SHEATH WAS SUCCESSFULLY ADVANCED OVER AORTA, PTA ADVANCE D IN STENT,
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9231498 ↗
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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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