EverCross™ AB35W08080135 (UDI 00643169974357)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169974357), received between Sep 23, 2021 and Sep 23, 2021 — 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 23, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID LEFT SU PERFICIAL FEMORAL ARTERY WITH 70% STENOSIS. THERE WAS NO VESSEL TORTUOSITY AND THE VESSEL WAS ECTATIC. THE ARTERY DIAMETER WAS 7.5MM AND LESION LENGTH WAS 300MM. A NON MEDTRONIC 6FR SHEATH AND 0.035'' GUIDEWIRE WERE USED. NO EMBOLIC PROTECTION WAS USED. THE BALLOON WAS INFLATED WITH A NON MEDTRONIC INFLATION DEVICE. CONTRAST INFLATION FLUID WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED PER IFU. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE. IT WAS REPORTED THAT THE BALLOON BURST AT 12 ATM AFTER 2 INFLATIONS. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EVERCROSS BALLOON WITH NO ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518618 ↗