Fortrex™ A35HPV06080080Recalls & reported problems
Medtronic, Inc. · PTA A35HPV06080080 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 00763000634520), received between Nov 20, 2025 and Nov 20, 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
- 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.
MalfunctionNov 20, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash
IT WAS REPORTED THAT DURING A PROCEDURE USING THE 035 HPV 06X080X80, THERE WERE ALLEGATIONS OF BALLOON BURST/BALLOON LEAK/CATHETER LEAK. THE DEGREE OF CALCIFICATION WAS DESCRIBED AS MODERATE. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605760 ↗
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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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