BEUDAMED
    FDA Recall 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 · Initiated April 1, 2014

    Recall

    Recall Number
    Z-0477-2015
    Event Number
    69735
    Firm
    ZOLL Circulation, Inc.
    FEI Number
    3003793491
    Product Code
    PAV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 1, 2014
    Posted
    December 3, 2014
    Terminated
    November 26, 2014
    Address
    2000 Ringwood Ave, San Jose, CA, 95131-1728

    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.

    Action

    Hospital was notified in April 2014 of the recall by UPS.

    Distribution

    One location in NC

    Quantity

    1 device