EverCross™ AB35W04060080Recalls & reported problems
Ev3, Inc · PTA AB35W04060080 EVERCROSS 035 V09 · Class 2
All models of EverCross (114)
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 00763000186098), received between Feb 16, 2023 and Feb 16, 2023 — 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.
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.
MalfunctionFeb 16, 2023Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON DURING AN LEFT AV FISTULOPLASTY PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING BALLOON INFLATION THE BALLOON BURST BEFORE REACHING NOMINAL PRESSURE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. ANOTHER BALLOON OF THE SAME SIZE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY REPORT FOR THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16386999 ↗
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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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