EverCross™ AB35W03080135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169973299), received between Jan 11, 2024 and Jan 11, 2024 — 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.

• MalfunctionJan 11, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERCROSS TO TREAT A CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS SEVERE. LESION STENOSIS WAS CTO (CHRONIC TOTAL OCCLUSION 100%). EMBOLIC PROTECTION WAS NOT USED. A 6-0 SPIDER WAS USED. A MERIT INFLATION DEVICE WAS USED. IFU WAS FOLLOWED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THERE WAS A CIRCUMFERENTIAL/RADIAL BURST DURING BALLOON INFLATION AT 3ATMS ON THE FIRST INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. IT WAS REPORTED THAT BALLOON DID NOT CROSS EASILY OVER SPIDER WIRE BUT WAS ABLE TO CROSS LESION. CROSSED LESION, PHYSICIAN BEGAN TO INFLATE AND NOTICED BALLOON WAS BURST. PROCEDURE COMPLETED BY SWAPPING BALLOON OUT FOR NANOCROSS OF THE SAME SIZE AND INFLATED WITH NO ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18493344 ↗