BEUDAMED
    FDA Recall Terminated

    CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a Biosense Webster electrophysiology catheter and the appropriate equipment. This cable may be re-used subject to established cleaning and sterilization restrictions

    Recall: Z-0884-2011 · Initiated October 5, 2010

    Recall

    Recall Number
    Z-0884-2011
    Event Number
    56986
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    DSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 5, 2010
    Posted
    January 7, 2011
    Terminated
    May 7, 2012
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a Biosense Webster electrophysiology catheter and the appropriate equipment. This cable may be re-used subject to established cleaning and sterilization restrictions

    Reason

    When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.

    Action

    Biosense Webster issued an Urgent Field Safety Notice letter dated October 5, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to return the affected cable, accompanied by the attached Return Authorization form. For questions regarding this recall call Biosense Webster at 909 839-8874.

    Distribution

    Worldwide Distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, and WV, and the countries of Belgium, China, Israel, Japan, Singapore, and Thailand.

    Quantity

    1692