BEUDAMED
    FDA Enforcement Class II Terminated

    Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

    Recall: Z-0525-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0525-2015
    Event ID
    69764
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Concentric Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    September 26, 2013
    Classification Date
    December 8, 2014
    Termination Date
    December 8, 2014
    Address
    301 E Evelyn Ave, N/A, Mountain View, CA, 94041-1530, United States

    Description

    Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

    Reason

    Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.

    Code Info

    Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014

    Distribution

    US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.

    Quantity

    87 units