EverCross™ AB35W07060080 (UDI 00643169974111)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169974111), received between Sep 30, 2020 and Sep 30, 2020 — 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.

• InjurySep 30, 2020Burst 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 INTENDED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 60MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL RIGHT COMMON ILIAC ARTERY. ARTERY DIAMETER REPORTED AS 7MM. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. CALCIFICATION IS REPORTED THROUGHOUT THE LEG INCLUDED THE AFFECTED AREA. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. EMBOLIC PROTECTION WAS NOT USED. AN ANGIOGRAM PERFORMED PRIOR TO BALLOON ANGIOPLASTY. THERE WAS NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE BALLOON WAS PLACED THROUGH THE UP AND OVER SHEATH, FROM LEFT FEMORAL ACCESS. THE SHEATH WAS PULLED BACK, SO BALLOON WAS ACROSS THE ILIAC BIFURCATION. IT IS REPORTED A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED AT A PRESSURE OF 12ATM ON FIRST INFLATION OF THE DEVICE. PHYSICIAN ATTEMPTED TO REMOVE BALLOON, BUT IT WAS STUCK ON THE CALCIFIED LESION. USING FORCE ON REMOVAL THE BALLOON CATHETER BROKE. THE MAIN SECT

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10605144 ↗