EverCross™ AB35W10060135 (UDI 00763000185039)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000185039), received between Apr 1, 2025 and Apr 4, 2025 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DEVICE FOR PATIENT TREATMENT IN THE MID ILIAC ARTERY ¿ COMMON REPORTED TO BE FIBROUS AND EXHIBITING PLAQUE WITH MODERATE TORTUOSITY AND CALCIFICATION WITH 80% STENOSIS. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. BALLOON WAS INFLATED USING A SYRINGE. DEVICE PREPPED AS PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT A KINK/TWIST WAS NOTED AT THE TIP OF THE BALLOON. THE BALLOON WAS USED FOR DILATATION. AFTER THE BALLOON WAS REMOVED, IT WAS FOUND THAT THERE WAS A CREASE AT THE TIP OF THE BALLOON, AND IT COULD NOT BE DILATED NORMALLY. THEN A NEW BALLOON WAS REPLACED AND DILATED NORMALLY. THE NEW BALLOON WAS REPLACED AND DILATED AGAIN, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771277 ↗
• MalfunctionApr 1, 2025Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  IT WAS REPORTED THAT DURING PROCEDURE USING THE EVERCROSS BALLOON, THE PATIENT WAS DIAGNOSED WITH ILIAC ARTERY SCLEROSIS AND OCCLUSION. ANGIOGRAPHY CONFIRMED ILIAC ARTERY STENOSIS WITH 80% LESION STENOSIS IN THE PROXIMAL COMMON ILIAC ARTERY. THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER WAS USED FOR DILATATION, AND THE BALLOON WAS INFLATED TO THE RATED STANDARD PRESSURE. HOWEVER, THE BALLOON WAS WITHDRAWN AND IT WAS FOUND IT DID NOT DEFLATE WELL. AFTER WITHDRAWING THE BALLOON, BLOOD WAS FOUND INSIDE THE BALLOON, INDICATING A RUPTURE. THE BALLOON WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741383 ↗