EverCross™ AB35W07040080 (UDI 00763000766719)Recalls & reported problems
Medtronic, Inc. · PTA AB35W07040080 EVERCROSS 035 V10 · Class 2
All models of EverCross (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000766719), received between Feb 16, 2026 and Feb 16, 2026 — classified as 1 injury.
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
- Fistula1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2026Burst Container or Vessel
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY EVERCROSS 035, A FISTULA WAS ASSOCIATED WITH THE EVENT. THE BALLOON BURST AT A PRESSURE OF 7 ATM, AND A SURGICAL CUT DOWN INTERVENTION WAS PERFORMED DURING THE PROCEDURE. THE INFLATION FLUID USED WAS A 50/50 CONTRAST MIXTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Fistula
MAUDE report 24343751 ↗
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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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