Fortrex™ A35HPV12080135 (UDI 00763000634957)Recalls & reported problems
Medtronic, Inc. · PTA A35HPV12080135 FORTREX V04 · Class 2
All models of Fortrex (14)
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 00763000634957), received between May 26, 2025 and May 26, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
- 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.
MalfunctionMay 26, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash
PHYSICIAN ATTEMPTED TO USE A FORTREX HIGH PRESSURE DILATATION BALLOON DEVICE FOR PATIENT TREATMENT IN THE BASILIC VEIN WITH MODERATE TORTUOSITY AND 80% STENOSIS. DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT A BALLOON PIN HOLE LEAK/BURST WAS REPORTED DURING INFLATION. DURING THE PROCEDURE, THE DOCTOR REPORTED THE BALLOON RUPTURED REACHING 10 ATM. WHEN THE RUPTURE REACHED 12 ATM, THE BALLOON WAS WITHDRAWN BY APPLYING PRESSURE, PUTTING RESISTANCE AS IT CAME OUT THROUGH THE 7FR INTRODUCER SHEATH. WHEN REMOVING THE BALLOON, HE NOTICED THAT THE INTRODUCER SHEATH WAS WRINKLED, AND HE HAD TO COMPLETELY WITHDRAW THE SYSTEM, LEAVING ONLY A GUIDE AS A LUMEN TOWARDS THE VEIN. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE INTRODUCER SHEATH WAS CHANGED AND THE PROCEDURE COMPLETED. NO PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083649 ↗
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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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