EverCross™ AB35W07100135 (UDI 00643169974166)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169974166), received between May 10, 2021 and May 21, 2025 — 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.

• MalfunctionMay 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING THE EVERCROSS 035 BALLOON, THE DEVICE WOULD NOT FULLY INFLATE DUE TO A KINK CAUSING TWISTING IN THE MIDDLE OF THE BALLOON. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM PACKAGING.THE EVENT OCCURRED AT THE PERIPHERAL ARTERY, SPECIFICALLY THE SUPERFICIAL FEMORAL ARTERY, WITH MINIMAL TORTUOSITY NOTED. THE LESION WAS A SOFT TISSUE LESION. A DOG-BONE TWIST WAS VISIBLE WITHIN THE BALLOON IN THE VESSEL. IT IS NOT KNOWN IF A RE-WRAP TOOL WAS USED. THE VESSEL WAS POST-DILATED USING THE EVERCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE, WHICH WAS A MEDTRONIC PRODUCT. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT ON THE PATIENT. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059945 ↗
• MalfunctionMay 10, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE TWO EVERCROSS PTA BALLOON DEVICE TO TREAT A RIGHT MID/DISTAL SUPERFICIAL FEMORAL ARTERY POPLITEAL ARTERY LESION IN A PATIENT WITH 85% STENOSIS AND LITTLE TORTUOSITY AND SEVERE CALCIFICATION (CTO). A 0.035NON MEDTRONIC WIRE WAS USED WITH A NON-MEDTRONIC SHEATH AND NON-MEDTRONIC INFLATION DEVICE. THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT THE FIRST BALLOON BURST OCCURRED DURING INFLATION AT 10ATMS DURING THE 1ST INFLATION. THE SECOND BALLOON BURST OCCURRED DURING INFLATION AT 8ATMS DURING THE 1ST INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING (SHELF CARTON, HOOP/TRAY). HEAVILY CALCIFIED SFA LESION, BOTH BALLOONS USED RUPTURED. ALL FRAGMENTS WERE REMOVED WITH NO VESSEL DAMAGE AS PER PHYSICIAN. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED. PROCEDURE WAS COMPLETED WITH STENTING NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798807 ↗
• MalfunctionMay 10, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE TWO EVERCROSS PTA BALLOON DEVICE TO TREAT A RIGHT MID/DISTAL SUPERFICIAL FEMORAL ARTERY POPLITEAL ARTERY LESION IN A PATIENT WITH 85% STENOSIS AND LITTLE TORTUOSITY AND SEVERE CALCIFICATION (CTO). A 0.035NON MEDTRONIC WIRE WAS USED WITH A NON-MEDTRONIC SHEATH AND NON-MEDTRONIC INFLATION DEVICE. THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT THE FIRST BALLOON BURST OCCURRED DURING INFLATION AT 10ATMS DURING THE 1ST INFLATION. THE SECOND BALLOON BURST OCCURRED DURING INFLATION AT 8ATMS DURING THE 1ST INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING (SHELF CARTON, HOOP/TRAY). HEAVILY CALCIFIED SFA LESION, BOTH BALLOONS USED RUPTURED. ALL FRAGMENTS WERE REMOVED WITH NO VESSEL DAMAGE AS PER PHYSICIAN. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED. PROCEDURE WAS COMPLETED WITH STENTING NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798773 ↗