NanoCross™ Elite AB14W050120150 (UDI 00763000758141)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000758141), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 10, 2024Open, Classified

   There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

   Z-0904-2025 · Root cause: Process change control · FDA record ↗

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.

• InjuryJan 7, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A NANOCROSS ELITE BALLOON, DEFLATION DIFFICULTIES WITH THE BALLOON WERE NOTED, THE DEVICE DID NOT FULLY DEFLATE FOR REMOVAL. A 5FR SHEATH AND A 0.014" NON MEDTRONIC GUIDEWIRE WERE USED. A NON MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST INFLATION FLUID. THE BALLOON WAS EVENTUALLY DEFLATED USING NEGATIVE PRESSURE AND BREAKING THROUGH THE SHEATH. THE PROCEDURE WAS ADDRESSING A LESION IN THE MID-LEFT POPLITEAL ARTERY WITH A LENGTH OF 120 MM, ASSOCIATED WITH PERIPHERAL ARTERY DISEASE AND PLAQUE. A NEW NON MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21090128 ↗