BEUDAMED
    FDA Recall Terminated

    MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.

    Recall: Z-1701-2018 · Initiated February 26, 2018

    Recall

    Recall Number
    Z-1701-2018
    Event Number
    79463
    Firm
    Micro Therapeutics Inc, Dba Ev3 Neurovascular
    FEI Number
    3004904811
    Product Code
    NRY
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 26, 2018
    Posted
    May 16, 2018
    Terminated
    September 30, 2021
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811

    Description

    MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.

    Reason

    There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.

    Action

    The firm initiated their recall via an Urgent Medical Device Recall letter, dated February 26, 2018. The letter identified the affected device, described the issue, product scope, and the actions to be taken. The firm recommended users remove and quarantine all affected and unexpired product in their inventory and return the affected products to Medtronic. Customers may contact their Medtronic representative if alternative product is needed. The Customer Confirmation Form should be completed and faxed to Medtronic at 1-949-434-5020, to the attention of Neurovascular Quality.

    Distribution

    Worldwide Distribution

    Quantity

    1,942 units