Fortrex™ A35HPV06100135Recalls & reported problems
Covidien LP · PTA A35HPV06100135 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 00763000106058), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Inflation Problem1
- Leak/Splash1
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.
MalfunctionFeb 19, 2025Inflation Problem; Leak/Splash; Difficult to Advance; Inflation Problem; Leak/Splash; Difficult to Advance
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING A FORTREX BALLOON, THERE WERE DIFFICULTIES INFLATING THE BALLOON, DUE TO A BALLOON LEAK. ADDITIONALLY, THERE WERE ISSUES WITH POOR GUIDEWIRE MOVEMENT, DIFFICULTIES LOADING OR EXCHANGING THE GUIDEWIRE, AND RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE INVOLVED THE RIGHT RADIAL ARTERY, SPECIFICALLY TARGETING A PROXIMAL FIBROUS LESION WITH 90% STENOSIS, MODERATE TORTUOSITY, AND LITTLE CALCIFICATION. THE ARTERY DIAMETER WAS 2.1 MILLIMETERS, AND THE LESION LENGTH WAS 5 MILLIMETERS. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE AT A PRESSURE OF 12 ATM, AND THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. THE PROCEDURE WAS COMPLETED BY REPLACING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21409811 ↗
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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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