EverCross™ AB35W08040080 (UDI 00643169974296)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169974296), received between Apr 11, 2022 and Apr 11, 2022 — classified as 1 injury.

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.

• InjuryApr 11, 2022Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT SUPERFICIAL FEMORAL ARTERY. A 6FR SHEATH AND 0.035'' GUIDEWIRE WERE USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE BALLOON BURST UNDER LOW PRESSURE 5-6 ATM. THE BALLOON WAS DISLOCATED COMPLETELY FROM THE SHAFT. THE BALLOON COULDN'T BE REMOVED FROM THE VESSEL, SO IT HAD TO BE TRAPPED WITH A COVERED STENT IN THE DISTAL ILIAC ARTERY. PHYSICIAN STATED THAT 'NORMALLY IF I SEE THAT A BALLOON IS DESTROYED, THE COVERING IS ON THE BALLOON, BUT IN THIS CASE IT WAS AWAY'. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14071599 ↗