Fortrex™ A35HPV06100080 (UDI 00763000634551)Recalls & reported problems
Medtronic, Inc. · PTA A35HPV06100080 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 00763000634551), received between Aug 12, 2025 and Aug 12, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
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 12, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX BALLOON, A 75% LESION STENOSIS WAS PRESENT IN THE LEFT MID CEPHALIC VEIN AT THE FOREARM. THE BALLOON EXPERIENCED A PIN HOLE BURST DURING THE FIRST INFLATION AT 23 ATM. DURING REMOVAL, THE BALLOON BECAME STUCK IN THE SHEATH, REQUIRING THE SURGEON TO LOOSEN THE SHEATH FOR COMPLETE AND SAFE REMOVAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22782700 ↗
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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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