EverCross™ AB35W10040080 (UDI 00763000185008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000185008), received between Jul 1, 2019 and Dec 1, 2023 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionDec 1, 2023Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DURING PATIENT TREATMENT. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A BALLOON BURST WAS REPORTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246494 ↗
• InjuryJul 1, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING AN EVERCROSS PTA BALLOON TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, FIBROUS LESION IN THE MID RIGHT SUBCLAVIAN ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 7FR NON-MEDTRONIC SHEATH WAS USED WITH NO EMBOLIC PROTECTION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. THE DEVICE WAS INFLATED TO 8ATM USING AN INFLATION DEVICE AND A MIX OF SALINE/CONTRAST AS INFLATION FLUID. IT WAS REPORTED THAT THE BALLOON BURST ON THE FIRST INFLATION AND FRAGMENTED. PART OF THE BALLOON REMAINED IN THE PATIENTS ARTERY SO, AN 8X80X80 STENT WAS USED TO CAGE IT AGAINST THE VESSEL WALL. A NEW BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8748332 ↗