EverCross™ AB35W10020080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684062210), received between Mar 20, 2019 and Mar 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionMar 20, 2019Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  THE PHYSICIAN USED AN EVERCROSS TO TREAT A SOFT TISSUE LESION IN THE MID COMMON FEMORAL ARTERY. A NON MEDTRONIC 8FR SHEATH AND A 0.35 X 260 GUIDEWIRE WAS USED FOR THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE BALLOON WAS USED TO TREAT THE AREA AND WAS INFLATED USING AN INFLATION DEVICE. IT WAS REPORTED THAT THE BALLOON DETACHED DURING REMOVAL OF THE DEVICE FROM THE SHEATH AT THE END OF THE PROCEDURE. THE BALLOON DETACHED IN THE SHEATH AND BOTH THE DEVICE AND SHEATH WERE REMOVED TOGETHER. THE PHYSICIAN WAS UNSURE IF THE BALLOON HAD COMPLETELY DEFLATED. THE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8435863 ↗