EverCross™ AB35W08040135 (UDI 00763000184803)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000184803), received between Dec 26, 2019 and Nov 26, 2021 — classified as 2 malfunctions.

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.

• MalfunctionNov 26, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERCROSS PTA DURING ALONG WITH 5.0 SPIDER FX EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID TO DISTAL POPLITEAL ARTERY (POP) WITH 40% STENOSIS. THE VESSEL WAS NONE TORTUOUS. A MEDTRONIC INFLATION DEVICE WAS USED FOR INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, A BURST OCCURRED AND ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PTA BALLOON DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING DEVICE. PROCEDURE WAS COMPLETED AFTER BALLOON BURST. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877936 ↗
• MalfunctionDec 26, 2019Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A PLAQUE LESION IN THE PATIENTS¿ MID SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 60% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED THAT A LONGITUDINAL BALLOON BURST OCCURRED DURING BALLOON INFLATION AT A PRESSURE OF 8ATM. NO BALLOON FRAGMENTS WERE LEFT IN THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER MEDTRONIC DEVICE TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519252 ↗