NanoCross™ Elite AB14W040040150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000757908), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 other recall cover devices cleared under the same FDA submission (K141118); they may or may not involve this specific model.

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 18, 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.

• MalfunctionJan 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014 DEVICE, A LEAK WAS NOTED IN THE BALLOON. THE PROCEDURE INVOLVED ADDRESSING A PLAQUE IN THE MID-SECTION OF THE RIGHT POPLITEAL ARTERY. THE LEAK WAS IDENTIFIED DURING THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THE NEW DEVICE USED WAS A 4 X 40 NANCROSS. THE DEVICE WAS SAFELY REMOVED, AND THERE WERE NO INJURIES OR INTERVENTIONS ASSOCIATED WITH THIS EVENT. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093532 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141118. One submission often covers many models, so check the product and lot details in each record.

• Z-0904-2025 · Dec 10, 2024 · Open, Classified
  Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090,