EverCross™ AB35W07040135 (UDI 00643169974098)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169974098), received between Nov 5, 2020 and May 23, 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.

• InjuryMay 23, 2023Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE AN EVERCROSS TO TREAT A CALCIFIED LESION IN THE RIGHT MID DISTAL ILIAC ARTERY - COMMON. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS SEVERE. LESION STENOSIS WAS CTO (CHRONIC TOTAL OCCLUSION-100%). A 6 FR NON-MEDTRONIC SHEATH WAS USED. A NON-MEDTRONIC 035 GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. SALINE/CONTRAST MIX INFLATION FLUID WAS USED. DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT.  RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE LESION WAS CROSSED WITH MILD DIFFICULTY AND PRE-DILATED WITH A 4X60 EVERCROSS WITH NO ISSUES. THE 7X40 EVERCROSS WAS THEN INSERTED AND IT IS REPORTED THAT THE BALLOON BURST AT 7 ATMS ON FIRST INFLATION. THERE WERE REMOVAL DIFFICULTIES UPON DEFLATION AND THE CATHETER AND BALLOON WERE NOT ABLE TO BE REMOVED. NEGATIVE PRESSURE WAS THEN APPLIED TO BALLOON AGAIN WHERE IT WAS FOUND THAT BALLOON HAD RUPTURED. A BREAK/FRACTURE OCCURRED AT THE BALLOON CATHETER TIP. THE CATHETER WAS THEN ABLE TO BE REMOVED THROUGH 6 FR SHEATH, BU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982261 ↗
• MalfunctionNov 5, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT A PLAQUE LESION IN THE PATIENT¿S COMMON ILIAC ARTERY. SLIGHT VESSEL CALCIFICATION AND NO TORTUOSITY ARE REPORTED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED THAT A BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 10ATM. NO FRAGMENTS REMAIN IN THE PATIENT. A SECOND EVERCROSS BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10792112 ↗