Fortrex A35HPV04040080Recalls & reported problems
Covidien LP · 0.035 IN OTW PTA Balloon Catheter · 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 00821684057216), received between Feb 2, 2018 and Feb 2, 2018 — 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 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.
MalfunctionFeb 2, 2018Burst Container or Vessel; Burst Container or Vessel
THE PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON CATHETER TO DILATE AN EXISTING STENT IN THE SFA. THE LESION WAS A 40 MM MODERATELY CALCIFIED PLAQUE LESION IN THE RIGHT PROXIMAL SFA (80% STENOSIS). THE ARTERY HAD LITTLE TORTUOSITY AND WAS 5 MM IN DIAMETER. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.035" 260 CM NON-MEDTRONIC GUIDEWIRE. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST AND NORMAL SALINE. IT WAS REPORTED THAT THE BALLOON RUPTURED AT 22 ATM PRESSURE. NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER FORTREX BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7236527 ↗
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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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