NanoCross™ Elite AB14W020080150 (UDI 00763000109486)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000109486), received between Mar 26, 2021 and Feb 11, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING A NANOCROSS 014 BALLOON TO TREAT A 70% LESION STENOSIS IN THE ANTERIOR TIBIAL ARTERY, BALLOON INFLATION DIFFICULTIES WERE OBSERVED. A LEAK WAS NOTED ON THE DEVICE. THE BALLOON BODY HAD AIR LEAKAGE. THE LESION WAS LOCATED DISTALLY IN THE ARTERY AND WAS DESCRIBED AS HAVING LITTLE CALCIFICATION AND TORTUOSITY. THE BALLOON WAS INFLATED USING A SYRINGE, AND INFLATION DIFFICULTIES WERE NOTED AT AN INFLATION PRESSURE OF 6 ATM. THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON WITH THE SAME MODEL FOR DILATATION. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354967 ↗
• MalfunctionMar 26, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT THE ANTERIOR TIBIAL ARTERY (ATA). THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE BALLOON BURST BELOW THE NOMINAL PRESSURE. ALL OF THE BALLOON WAS NOT REMOVED FROM PATIENT. DEVICE WAS REMOVED SAFELY FROM PATIENT. NO INTERVENTION WAS REQUIRED TO REMOVE BALLOON FRAGMENTS. THERE WAS NO VESSEL DAMAGE NOTED. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575397 ↗

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,