Fortrex™ A35HPV07100080 (UDI 00763000634674)Recalls & reported problems
Medtronic, Inc. · PTA A35HPV07100080 FORTREX V04 · Class 2
All models of Fortrex (14)
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 00763000634674), received between Aug 7, 2024 and Aug 7, 2024 — 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.
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.
MalfunctionAug 7, 2024Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash
PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER WITH A 7FR NON-MEDTRONIC SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A FIBROUS LESION IN THE PATIENTS LEFT MID BRACHIAL ARTERY (ARTERIOVENOUS FISTULA). MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU (INSTRUCTION FOR USE) WITH NO ISSUES IDENTIFIED. EMBOLIC PROTECTION WAS NOT USED. A MEDTRONIC EVEREST 30 INFLATION DEVICE WAS USED. SALINE INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A PIN HOLE BALLOON LEAK WAS NOTED DURING BALLOON INFLATION AT 20 ATMS. THE BALLOON DID NOT DETACH DURING EVENT. ANOTHER BRAND OF BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19927465 ↗
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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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