EverCross™ AB35W06040040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169973855), received between Feb 17, 2020 and Feb 17, 2020 — 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.

• MalfunctionFeb 17, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR NON-MEDTRONIC (TERUMO) SHEATH AND NON-MEDTRONIC (BENTSON) GUIDEWIRE DU RING TREATMENT OF A 5MM PLAQUE LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 75% STENOSIS. NO DAMAGE NOTED TO THE PACKAGING PRIOR TO USE. NO ISSUES 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 AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. A NON-MEDTRONIC (PRESTO) INFLATION DEVICE WAS USED WITH HEPARINIZED SALINE AND VISIPAQUE FOR BALLOON INFLATION. IT IS REPORTED A BALLOON RUPTURE OCCURRED AT 10ATM DURING THE FIRST INFLATION. ALL COMPONENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ISSUE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716397 ↗