EverCross™ AB35W05040135 (UDI 00763000184148)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000184148), received between Aug 23, 2019 and Feb 3, 2023 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AN EVERCROSS PTA BALLOON WAS BEING USED DURING THE TREATMENT OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THE BALLOON RUPTURED IN THE PATIENT AND WAS WITHDRAWN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16290873 ↗
• MalfunctionNov 12, 2021Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT'S MID SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL CALCIFICATION IS REPORTED. LESION EXHIBITED 80% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT AND NO EXCESSIVE FORCE WAS USED. THE BALLOON WAS FOUND TO BE LEAKING DURING USE AND CANNOT BE USED MULTIPLE TIMES. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802046 ↗
• MalfunctionAug 23, 2019Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED AN EVERCROSS BALLOON WITH A 6FR SHEATH AND 0.011" GUIDEWIRE DURING TREATMENT OF A 100MM PLAQUE LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 4MM. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. IFU WAS FOLLOWED, DEVICE PREPPED WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED EVERFLEX ENTRUST STENT WITHOUT RESISTANCE. AN INFLATION DEVICE WAS USED WITH 50/50 INFLATION FLUID. IT IS REPORTED DURING BALLOON INFLATION AT A PRESSURE OF 8ATM A PIN HOLE BURST OCCURRED. THIS OCCURRED ON SECOND INFLATION OF THE BALLOON IN AN INTRASTENT STENT. NO FRAGMENTS OF THE BALLOON REMAINED IN THE PATIENT. AN 8X60 EVERCROSS BALLOON WAS THEN USED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924962 ↗