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NanoCross™ Elite AB14W040100150Recalls & reported problems

Ev3, Inc · PTA AB14W040100150 NANOCROSS 014 V04 · Class 2

All models of NanoCross Elite (63)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684066782), received between Dec 4, 2018 and Dec 4, 2018 — classified as 1 injury.

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

Device problems

  • Burst Container or Vessel1
  • Detachment of Device or Device Component1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 4, 2018Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

    THE PHYSICIAN INTENDED TO USE THE NANOCROSS BALLOON WITH A 6F NON-MEDTRONIC SHEATH AND A NITREX 014 GUIDEWIRE TO TREAT A SEVERELY CALCIFIED LESION WITH 85%STENOSIS IN THE POPLITEAL, TIBIAL/POPLITEAL TRUNK AND ANTERIOR TIBIAL ARTERY. ARTERY DIAMETER 4MM, LESION LENGTH 100MM. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE OR EXCESSIVE FORCE WAS USED. IT WAS REPORTED THE DURING FIRST INFLATION THE BALLOON BURST RADIALLY AT 3ATMS. THE CATHETER WAS REMOVED FROM THE PATIENT. THE BALLOON WAS REMOVED FROM THE PATIENT IN PIECES AND THE DISTAL PORTION OF THE BALLOON COULD NOT BE REMOVED AND REMAINS IN THE ANTERIOR TIBIAL ARTERY OPPOSED TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED AT THIS POINT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8127959 ↗

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,

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page