BEUDAMED
    FDA Recall Terminated

    PENTARAY NAV High-Density Mapping Catheter.

    Recall: Z-0211-2018 · Initiated May 17, 2017

    Recall

    Recall Number
    Z-0211-2018
    Event Number
    77529
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    MTD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 17, 2017
    Terminated
    December 15, 2020
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    PENTARAY NAV High-Density Mapping Catheter.

    Reason

    Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.

    Action

    Recall Notification letter, dated 04/14/2016, and Acknowledgement Form was sent to customers via express mail on 05/17/2017. Instructions included to read and follow Labeling Correction Notice carefully, provide the notice to anyone in the facility that should be aware, sign and return the Acknowledgement Form, and to maintain awareness of the correction.

    Distribution

    Nationwide Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Oman, People's Republic of China, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    73,796 units total