Fortrex™ A35HPV06040135 (UDI 00763000105990)Recalls & reported problems
Covidien LP · PTA A35HPV06040135 FORTREX V02 · Class 2
All models of Fortrex (34)
Data updated Oct 18, 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 00763000105990), received between Jun 4, 2020 and Jun 4, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Most reported problems
Device problems
- 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.
MalfunctionJun 4, 2020Leak/Splash; Leak/Splash
PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA BALLOON CATHETER ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014 GUIDE WIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT MID SFA WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS SEVERELY TORTUOUS WITH 6MM DIAMETER. THERE WERE NO DAMAGES TO THE PACKAGINGS. THERE WERE NO ISSUES NOTED WHEN REMOVING DEVICES FROM HOOP/TRAY. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE BALLOONS WERE INFLATED USING AN INFLATION DEVICE. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT WITH NO RESISTANCE FELT WHEN ADVANCING THE DEVICE. DURING PACIFIC XTREME BALLOON INFLATION, PIN HOLE LEAK WAS NOTED AT 8ATM. PHYSICIAN EXCHANGED FOR A FORTREX PTA BALLOON AND DURING BALLOON INFLATION, A PIN HOLE LEAK WAS ALSO NOTED AT 8ATM. IT WAS REPORTED THAT THE FIRST BALLOON RUPTURED AT THE DISTAL END PRIOR STENT IT WAS A 5X200X130 PACIFIC XTREME .018 BALLOON. THEN A 6X40X135 FORTREX BALLOON WAS USED AND ALSO RUPTURED. THEN A 6X60X120 EVERFLEX STENT WAS PLACED AT DISTAL END OF PREVIOUSLY DEPLOYED STENT. THEN A 6X20X135 FORTREX BALLOON WAS USED TO POST DILATE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10117668 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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