Fortrex™ A35HPV08080080 (UDI 00763000634735)Recalls & reported problems
Medtronic, Inc. · PTA A35HPV08080080 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 00763000634735), received between Aug 12, 2025 and Aug 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
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, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING USE OF THE FORTREX BALLOON, REMOVAL DIFFICULTIES OCCURRED, SPECIFICALLY DIFFICULTY REMOVING THE BALLOON FOLLOWING BALLOON INFLATION. THE OPERATOR WAS UNABLE TO PULL BACK THE BALLOON FROM THE SHEATH AFTER INFLATION AND HAD TO PULL OUT THE WHOLE SYSTEM TO RETRIEVE THE BALLOON. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED, AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED, AND EMBOLIC PROTECTION WAS NOT UTILIZED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22782797 ↗
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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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