EverCross™ AB35W04150135 (UDI 00763000184032)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000184032), received between Jun 28, 2021 and Jun 13, 2024 — classified as 3 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.

• MalfunctionJun 13, 2024Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  IA PHYSICIAN WAS USING AN EVERCROSS PTA BALLOON FOR TREATMENT OF A PLAQUE LESION WITH 60% STENOSIS IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. A SYRINGE WAS USED FOR INFLATION. IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH LOWER EXTREMITY ARTERIOSCLEROSIS AND OCCLUSION, AND WAS TO UNDERGO ARTERIAL BALLOON DILATATION AND STENT IMPLANTATION. AFTER ANGIOGRAPHY, IT WAS CONFIRMED THAT THE PATIENT HAD SUPERFICIAL FEMORAL ARTERY STENOSIS. FIRST, THE PTA BALLOON DILATATION CATHETER WAS USED FOR DILATATION. THE BALLOON WAS INFLATED TO THE RATED STANDARD PRESSURE AND THE BALLOON EXPANDED NORMALLY. THEN THE BALLOON WAS WITHDRAWN AND IT WAS FOUND THAT BALLOON DILATION WAS POOR. AFTER WITHDRAWAL, BLOOD WAS FOUND IN THE BALLOON. IT IS THOUGHT THE BALLOON HAD RUPTURED. ANOTHER BALLOON WAS USED TO COMPLETE THE SUBSEQUENT DILATATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528444 ↗
• MalfunctionJul 30, 2021Inflation Problem; Leak/Splash; Material Deformation; Inflation Problem; Leak/Splash; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE THE PTA BALLOON DURING PROCEDURE TO TREAT LITTLE CALCIFIED LESION IN THE MID COMMON ILIAC ARTERY WITH LITTLE TORTUOSITY. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE BALLOON WAS INFLATED WITH A SYRINGE. IFU WAS NOT FOLLOWED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THERE WERE BALLOON INFLATION DIFFICULTIES AT 10 ATM. THE BALLOON WAS UNABLE TO INFLATE AND ON INSPECTION IT WAS FOUND DAMAGED. THE BALLOON SURFACE WAS FOUND TO BE DAMAGE. LEAK WAS NOTED ON BALLOON. THE DEVICE WAS REMOVED SAFELY. THE PHYSICIAN REPLACED IT WITH ANOTHER BALLOON TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251134 ↗
• MalfunctionJun 28, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 50% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 100MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE SIZE AND MAKE OF THE SHEATH AND GUIDEWIRE WAS NOT PROVIDED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING BALLOON INFLATION, THE BALLOON BURST AT 8ATM DURING THIRD INFLATION. ALL FRAGMENTS OF THE BALLOON WAS RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. EXTREME RECOIL OF CALCIFIED SFA AFTER OCCURRED SEVERAL INFLATIONS. PHYSICIAN USED ADDITIONAL MEDTRONIC PTAS FOLLOWED BY A 5X120 INPACT ADMIRAL DCB TOCOMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075825 ↗