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NanoCross™ Elite AB14W030040150 (UDI 00763000109769)Recalls & reported problems

Ev3, Inc · PTA AB14W030040150 NANOCROSS 014 V05 · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000109769), received between Oct 1, 2021 and Oct 1, 2021 — classified as 1 malfunction.

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

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 1, 2021Burst Container or Vessel; Burst Container or Vessel

    PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT SEVERELY CALCIFIED LESION. A NON-MEDTRONIC GUIDEWIRE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THE BALLOON BURST INSIDE THE PATIENT AT 4ATM. THE BALLOON AND WIRE HAD TO BE REMOVED AS THEY COULD NOT BE SEPARATED. THE BALLOON WAS DESCRIBED AS 'LOOMING OUT IN PIECES'. THE BALLOON IS SUSPECTED TO HAVE FRAGMENTED BUT IT IS NOT CONFIRMED. NO INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE FROM THE PATIENT. THERE WAS NO VESSEL DAMAGE NOTED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO HARM TO PATIENT. NO EXCESSIVE FORCE WAS USED. THE PROCEDURE WAS COMPLETED USING NON MEDTRONIC BALLOONS. NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12561046 ↗

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

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