BEUDAMED
    FDA Enforcement Class II Terminated

    Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

    Recall: Z-1449-2015 · Reported April 22, 2015

    Enforcement

    Recall Number
    Z-1449-2015
    Event ID
    70847
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hansen Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 22, 2015
    Initiation Date
    March 18, 2015
    Classification Date
    April 15, 2015
    Termination Date
    September 23, 2015
    Address
    800 E Middlefield Rd, N/A, Mountain View, CA, 94043-4030, United States

    Description

    Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

    Reason

    Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released.

    Code Info

    All serial numbers.

    Distribution

    Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.

    Quantity

    19 total installed systems