EverCross™ AB35W07060135 (UDI 00763000766757)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000766757), received between Sep 2, 2025 and Sep 2, 2025 — classified as 2 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. 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.

• MalfunctionSep 2, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 BALLOON, A PATIENT WITH A SEVERELY CALCIFIED LESION IN THE COMMON ILIAC ARTERY (RIGHT AND LEFT, PROXIMAL AND MID SEGMENTS) EXPERIENCED BALLOON BURST ON FIRST INFLATION AT OR BELOW THE RATED BURST PRESSURE. A 6X11CM NON-MEDTRONIC SHEATH WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. THE BALLOON BURST OCCURRED WITH TWO SEPARATE EVERCROSS 035 DEVICES. THERE WAS NO INJURY TO THE PATIENT ASSOCIATED WITH THE BALLOON BURST, AND THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT AFTER EACH EVENT. THE PROCEDURE WAS COMPLETED USING A NEW 7X60 EVERCROSS DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932051 ↗
• MalfunctionSep 2, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 BALLOON, A PATIENT WITH A SEVERELY CALCIFIED LESION IN THE COMMON ILIAC ARTERY (RIGHT AND LEFT, PROXIMAL AND MID SEGMENTS) EXPERIENCED BALLOON BURST ON FIRST INFLATION AT OR BELOW THE RATED BURST PRESSURE. A 6X11CM NON MEDTRONIC SHEATH WAS USED. A NON MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. THE BALLOON BURST OCCURRED WITH TWO SEPARATE EVERCROSS 035 DEVICES. THERE WAS NO INJURY TO THE PATIENT ASSOCIATED WITH THE BALLOON BURST, AND THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT AFTER EACH EVENT. THE PROCEDURE WAS COMPLETED USING A NEW 7X60 EVERCROSS DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931742 ↗