EverCross™ AB35W06060080Recalls & reported problems
Medtronic, Inc. · PTA AB35W06060080 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000766511), received between Apr 30, 2025 and Apr 30, 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.
MalfunctionApr 30, 2025Burst Container or Vessel; Burst Container or Vessel
AN EVERCROSS PTA BALLOON WAS BEING USED FOR TREATMENT OF A CALCIFIED LESION IN THE PROXIMAL REGION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 7FR NON-MEDTRONIC SHEATH AND A 014 NITREX WIRE WERE USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST INFLATION FLUID. IT WAS REPORTED DURING THE FIRST INFLATION A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED. IT IS NOT KNOWN AT WHAT PRESSURE THE BALLOON BURST. THE DEVICE WAS SAFELY REMOVED, THE BALLOON DID NOT DETACH, AND THE PROCEDURE WAS COMPLETED USING ANOTHER EVERCROSS BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21933622 ↗
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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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