BEUDAMED
    FDA Enforcement Class II Terminated

    7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.

    Recall: Z-0477-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0477-2015
    Event ID
    69735
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ZOLL Circulation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    April 1, 2014
    Classification Date
    November 26, 2014
    Termination Date
    November 26, 2014
    Address
    2000 Ringwood Ave, N/A, San Jose, CA, 95131-1728, United States

    Description

    7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.

    Reason

    After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed.

    Code Info

    Model 1027, Catalog number 8700-000775-01, lot 0021.

    Distribution

    One location in NC

    Quantity

    1 device