EverCross™ AB35W08040135 (UDI 00763000766931)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000766931), received between Feb 5, 2025 and Feb 5, 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.

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.

• MalfunctionFeb 5, 2025Burst Container or Vessel; Device Damaged by Another Device; Burst Container or Vessel; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 BALLOONS, THE BALLOONS BURST DURING THE PROCEDURE AT A PRESSURE OF 8 ATMS ON THE FIRST INFLATION. THE PROCEDURE INVOLVED THE RIGHT PROXIMAL ILIAC ARTERY, WHICH WAS CALCIFIED WITH 80% STENOSIS AND A DIAMETER OF 8 MILLIMETERS. THE DEGREE OF TORTUOSITY WAS MINIMAL. A 6FR NON-MEDTRONIC SHEATH AND A 0.035" NON-MEDTRONIC GUIDEWIRE WERE USED.THE DEVICES WERE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT WITHOUT ENCOUNTERING RESISTANCE. THE BALLOONS WERE INFLATED USING AN INFLATION DEVICE WITH A 50/50 CONTRAST FLUID. THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT, AND THERE WERE NO INJURIES OR INTERVENTIONS ASSOCIATED WITH THE EVENT. THE PHYSICIAN BELIEVES THAT BOTH BALLOONS LIKELY GOT CAUGHT ON THE STRUT OF THE PREVIOUSLY IMPLANTED STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313168 ↗