EverCross™ AB35W07100080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000766788), received between Sep 30, 2026 and Sep 30, 2026 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Burst Container or Vessel

  It was reported that during post-dilation of a moderately calcified, minimally tortuous distal right common iliac artery lesion with an 8 mm vessel diameter, an EverCross 035 PTA balloon, burst at 6 atm during the first inflation. The balloon was advanced through a previously deployed EverFlex 8 mm x 100 mm x 80 mm stent over a .035 non Medtronic guidewire and inflated using a non Medtronic inflation device with 50/50 contrast. The instructions for use were followed without issue. The balloon was safely removed without detachment, and a new EverCross 035 PTA balloon, was used. During the first inflation at 6 atm, the second balloon burst. The second balloon was safely removed without detachment, and the physician ended the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944353 ↗