EverCross™ AB35W05100135 (UDI 00763000766351)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000766351), received between Dec 10, 2024 and Dec 10, 2024 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DEVICE EVERCROSS 035, A BALLOON BURST OCCURRED IN THE SUPERFICIAL FEMORAL ARTERY, RIGHT, DISTAL, WHICH WAS ASSOCIATED WITH A CALCIFIED LESION. THE PATIENT HAD A MEDICAL HISTORY OF PERIPHERAL ARTERY DISEASE (PAD). SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE DUE TO THE CALCIFIED LESION, AND THE BALLOON BURST DURING THE PROCEDURE. THE BALLOON WAS INFLATED USING A MEDTRONIC EVEREST INFLATION DEVICE WITH A 50/50 CONTRAST FLUID. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE, SPECIFICALLY A 5 X 60 NANOCROSS. ADDITIONALLY, THE STENT PROTEGE EF V10 FACED DIFFICULTIES DURING INSERTION DUE TO THE CALCIFIED LESION, BUT IT WAS ALSO SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW MEDTRONIC DEVICE, A 6 X 60 EVERFLEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892775 ↗