EverCross™ AB35W06100135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000184445), received between Jan 6, 2021 and Sep 8, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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.

• InjurySep 8, 2023Burst 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

  AN EVERCROSS PTA BALLOON WAS BEING USED DURING TREATMENT OF A CALCIFIED PLAQUE LESION WITH 70% STENOSIS IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY (SFA). THERE WAS MILD TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A NON MEDTRONIC INFLATION DEVICE WAS USED. THE BALLOON WAS USED FOR POST DILATION AFTER DEPLOYMENT OF 2 STENTS IN THE SFA. IT WAS REPORTED THE BALLOON BURST LONGITUDINALLY AT 12 ATM WITHIN THE STENT. THE PHYSICIAN TRIED TO PULL THE BALLOON OUT AND MADE IT A COUPLE OF INCHES OUT BEFORE THE BALLOON GOT STUCK ON THE STRUT. THE PHYSICIAN PULLED WITH FORCE AND THE BALLOON RIPPED OFF OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709455 ↗
• MalfunctionJan 6, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON AND NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A 200MM LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). HEAVY CALCIFICATION AND MINIMAL TORTUOSITY ARE REPORTED. LESION EXHIBITED 90% STENOSIS. THE VESSEL DIAMETER IS REPORTED AS 6MM. THERE WAS NO DAMAGE NOTED TO THE PRODUCT(S) PACKAGING PRIOR TO USE NOR ANY ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICES WERE PREPPED WITHOUT ISSUE. A 5FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE WERE USED DURING THE PROCEDURE. THE BALLOONS WERE INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE AND 50/50 FLUID SOLUTION. THE DEVICES WERE NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DEVICES. IT IS REPORTED THAT A PINHOLE BURST OCCURRED ON BOTH THE EVERCROSS PTA BALLOON AND THE NANOCROSS ELITE PTA BALLOON. THE EVERCROSS PTA BALLOON IS REPORTED TO HAVE BURST AT 8ATM AND THE NANOCROSS ELITE PTA BALLOON IS REPORTED TO HAVE BURST AT 10ATM. THE PROCEDURE WAS THEN COMPLETED WITH A NON-MEDTRONIC STENT AND BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123010 ↗