EverCross™ AB35W06060135 (UDI 00643169973893)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169973893), received between Jul 6, 2020 and Jul 6, 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.

• MalfunctionJul 6, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY AND EVERCROSS PTA BALLOON CATHETER DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) TO POPLITEAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE IFU WAS FOLLOWED. THE VESSEL WAS PRE AND POST DILATED. DURING INITIAL ADVANCEMENT SEVERE RESISTANCE WAS FELT WHILE ADVANCE THE DEVICE AND IT WAS UNABLE TO CROSS THE LESION. AN EVERCROSS PTA BALLOON WAS ATTEMPTED ALONG WITH SPIDER FX WIRE AND 7MM EMBOLIC PROTECTION. INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THE BALLOON DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING BALLOON INFLATION, THE BALLOON BURST AT 7ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE WHILE ADVANCING DEVICE TO LESION. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE AND THE LESION WAS ALSO STENTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10233118 ↗