BEUDAMED
    FDA Recall Terminated

    IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

    Recall: Z-0580-2015 · Initiated November 20, 2014

    Recall

    Recall Number
    Z-0580-2015
    Event Number
    69818
    Firm
    Boston Scientific Corp
    FEI Number
    3001236349
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 20, 2014
    Posted
    December 10, 2014
    Terminated
    August 11, 2016
    Address
    150 Baytech Dr, San Jose, CA, 95134-2302

    Description

    IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

    Reason

    Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.

    Action

    Urgent Medical Device Recall Correction Notification letters were sent on November 19, 2014 by overnight delivery. The letter identified the affected product and the problem. Customers were asked to read the Notification completely and ensure that all users are aware. The letter provides users with steps to mitigate the risk in the event that the identified problem occurs. Customers were also asked to complete and return the Customer Acknowledgement Form. A local sales representative can answer questions regarding the Field Correction.

    Distribution

    Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.

    Quantity

    184 units