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NanoCross™ Elite AB14W020150150Recalls & reported problems

Ev3, Inc · PTA AB14W020150150 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 00763000109547), received between Apr 26, 2021 and Apr 26, 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.

  • MalfunctionApr 26, 2021Burst Container or Vessel; Burst Container or Vessel

    IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DEVICE TO TREAT A MID SUPERFICIAL FEMORAL ARTERY LESION IN A PATIENT WITH 50% STENOSIS AND LITTLE TORTUOSITY AND MODERATE CALCIFICATION. A7F 45 SHEATH WAS USED, 0.014 NON-MEDTRONIC WIRE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT THE NANO CROSS PTA BURST AFTER ABOUT 1 MINUTE INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ATHERECTOMY, DCB, STENT-PLACEMENT, AND POST-STENT DILATION. NO PATIENT INJURY REPORTED FOR THIS EVENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11722753 ↗

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,

Other Catheter, angioplasty, peripheral, transluminal devices

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Sources and updates

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