EverCross™ AB35W08060135 (UDI 00763000184834)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000184834), received between Jul 2, 2024 and Apr 25, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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.

• MalfunctionApr 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO USE OF THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AB35W08060135 EVERCROSS 035 BALLOON, THERE WERE PACKAGING ISSUES. THE OUTER PACKAGE WAS DAMAGED, AND THERE WAS A TEAR ON THE PACKAGE, WHICH COMPROMISED THE STERILE PACKAGING. THE PROCEDURE INTENDED TO TREAT A CALCIFIED LESION IN THE RIGHT MID COMMON ILIAC ARTERY. THE DEVICE WAS NOT USED IN THE PATIENT, AND A NEW EVERCROSS 8X60X80 DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907761 ↗
• InjuryJul 2, 2024Burst 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

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS 035 PTA BALLOON WITH A 6FR SHEATH AND A .014 GUIDEWIRE DURING TREATMENT OF A 60MM FIBROUS LESION IN THE PATIENTS RIGHT MID COMMON ILIAC ARTERY. NO VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. ARTERY DIAMETER REPORTED AS 7.5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU (INSTRUCTION FOR USE) WITH NO ISSUES IDENTIFIED. EMBOLIC PROTECTION WAS NOT USED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. CONTRAST INFLATION FLUID WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED ON FIRST INFLATION AT 8ATMS. THE BALLOON BROKEN HORIZONTALLY AND HALF OF THE BALLOON WAS IN THE PATIENT'S BODY. DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION WAS ALSO REPORTED. PHYSICIAN MADE A CUT ON SKIN FOR RETRIEVAL OF THE DETACHED COMPONENT USING A SNARE. A REPLACEMENT NON-MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655429 ↗