BEUDAMED
    FDA Enforcement Class II Terminated

    PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

    Recall: Z-1176-2014 · Reported March 19, 2014

    Enforcement

    Recall Number
    Z-1176-2014
    Event ID
    67566
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biosense Webster, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 19, 2014
    Initiation Date
    February 20, 2014
    Classification Date
    March 11, 2014
    Termination Date
    October 24, 2014
    Address
    15715 Arrow Hwy, N/A, Irwindale, CA, 91706-2006, United States

    Description

    PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

    Reason

    Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the recall on 5/1/14 to include all lots of the PentaRay Nav Catheter and the PentaRay Nav ECO Catheter because they can lead to an insufficient bond of the distal tip to the catheter shaft.

    Code Info

    Lot Numbers: All Lots

    Distribution

    US Nationwide Distribution.

    Quantity

    15,672 units total (12,804 units in US)