EverCross™ AB35W07080080 (UDI 00643169974135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169974135), received between Feb 25, 2021 and Oct 5, 2021 — 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 18, 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.

• InjuryOct 5, 2021Burst Container or Vessel; Detachment of Device or Device Component; Difficult to Advance; Burst Container or Vessel; Detachment of Device or Device Component; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL AND MID LEFT COMMON ILIAC ARTERY. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED DURING ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. IT IS REPORTED THAT AFTER BALLOON INFLATION THE PHYSICIAN REALIZED THE BALLOON HAD RUPTURED. WHEN PHYSICIAN TRIED TO REMOVE THE BALLOON, HE FELT THE BALLOON BREAK. THE PHYSICIAN WAS USING A NON-MEDTRONIC GUIDEWIRE AT THE TIME. THE PROXIMAL PART OF THE BALLOON AND THE PROXIMAL AND DISTAL BALLOON MARKERS DID NOT COME OUT WHEN BALLOON WAS RETRIEVED. A SECOND .035 WIRE WAS INSERTED, AND A SELF-EXPANDING STENT WAS ADVANCED TO JAIL OFF THE BALLOON FRAGMENT. TWO STENTS WERE USED TO COMPLETELY JAIL OFF THE BALLOON AND MARKERS. A SHEATH WAS USED TO GET UP AND OVER AND TREAT THE OTHER LESIONS IN THE POPLITEAL (POP) AND SUPERFIC

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12575913 ↗
• MalfunctionFeb 25, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A 7FR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF AN AV FISTULA. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED DURING REMOVAL OF THE DEVICE FROM THE PACKAGING. SALINE AND CONTRAST WERE USED FOR BALLOON INFLATION. A BALLOON BURST IS REPORTED TO HAVE OCCURRED AT INFLATION TO APPROXIMATELY 14ATM. THE BALLOON WAS REMOVED, AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377355 ↗