BEUDAMED
    FDA Recall Terminated

    Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

    Recall: Z-1591-2016 · Initiated April 14, 2016

    Recall

    Recall Number
    Z-1591-2016
    Event Number
    73862
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    MTD
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    April 14, 2016
    Terminated
    October 14, 2016
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

    Reason

    Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.

    Action

    The firm, Biosense Webster, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 4/14/2016 to its customers. The letter described the product, problem and actions to be taken. The letter informs customers that the recall action is NOT a product removal, and that they may continue to use PENTARAY Catheters in accordance with the updated contraindication as stated in the recall letter. Customers are instructed to read and follow the Labeling Correction Notice carefully; pass on this letter to anyone in your facility that needs to be informed; maintain a copy of this letter with the PENTARAY Catheters, and sign and return the attached ACKNOWLEDGEMENT FORM immediately by email: [email protected], fax: 909-839-8514 or mail: Biosense Webster, Inc., Attn: FCA Coordinator,15715 Arrow Highway, Irwindale, CA 91706. The updated the IFU to clarify the contraindication statement as follows: "Do not use PENTARAY Catheters in patients with prosthetic valves". For questions related to this medical device correction, please contact your BWI sales representative or call 909-839-8500.

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Hong Kong, Indonesia, India, Japan, Korea, Malaysia, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Austria, Belgium, Bulgaria, Switzerland, Czech Republic, Germany, Denmark, Algeria, Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Israel, Iraq, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Turkey, South Africa.

    Quantity

    59,672 units