BEUDAMED
    FDA Recall Terminated

    Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P

    Recall: Z-0541-2007 · Initiated November 17, 2006

    Recall

    Recall Number
    Z-0541-2007
    Event Number
    36988
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2006
    Posted
    February 28, 2007
    Terminated
    June 25, 2009
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P

    Reason

    Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.

    Action

    Initially a Medical Device Correction Advisory letter was mailed on November 20, 2006 to all domestic and international consignees recommending to customers that the Preface Sheath was not to be used with the NaviStar ThermoCool Catheter or any 8 French or larger catheter. On December 9, 2006, a Recall Customer letter and Certification form were sent out to all customers and Johnson & Johnson affiliates who had purchased the product in the past three years. For customers in the US, two letters and forms were sent out -one addressed to the EP/Cardiology Lab and the second to the Risk Management Office. For the US, customers will return product directly to Biosense Webster afler receiving a return authorization number. Returned product will be segregated and labeled as quarantined product. Returned product will be used as necessary for the root cause investigation. Any product not used at the conclusion of the investigation will be destroyed. For international customers, product will be returned to the Biosense Webster warehouse in Roden, Netherlands or to the Biosense Webster US warehouse (depending on order placement) if export issues don''t present a problem. If product cannot be easily returned to Biosense Webster, the customers will be instructed to destroy the product and provide notification that the destruction was performed.

    Distribution

    Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.

    Quantity

    401