Fortrex™ A35HPV10040080 (UDI 00763000634858)Recalls & reported problems
Medtronic, Inc. · PTA A35HPV10040080 FORTREX V04 · Class 2
All models of Fortrex (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000634858), received between May 1, 2025 and Nov 12, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).
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 Vessel3
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING TREATMENT OF AN ARTERIOVENOUS (AV) FISTULA ON THE LEFT SIDE USING THE 10X40 FORTREX HP PTA BALLOON, THE BALLOON BURST ABOVE ITS RATED BURST PRESSURE AND DETACHED DURING THE EVENT. THE VESSEL WAS PRE-DILATED WITH AN 8X40 FORTREX HP PTA BALLOON. NOT ALL PIECES OR FRAGMENTS OF THE BALLOON WERE RETRIEVED FROM THE VESSEL, AND THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534557 ↗InjuryJun 23, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN AN ARTERIOVENOUS (AV) FISTULA USING THE FORTREX, THE BALLOON BURST AND A COMPONENT OF THE DEVICE DETACHED. THE DETACHED PORTION OF THE BALLOON REMAINED IN THE PATIENT AND WAS JAILED WITH A STENT. STENT PLACEMENT WAS PERFORMED AS AN INTERVENTION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 22307674 ↗MalfunctionMay 1, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE FORTREX 10X040X80 BALLOON, THE BALLOON BURST AT 16 ATM PRESSURE AND SUBSEQUENTLY DETACHED. AN INFLATION DEVICE AND 50/50 CONTRAST WERE USED FOR BALLOON INFLATION. A PORTION OF THE DEVICE REMAINED IN THE PATIENT WITHOUT INTERVENTION. THE TARGET LESION WAS NOTED TO BE CALCIFIED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941325 ↗
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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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