BEUDAMED
    FDA Recall Terminated

    Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]

    Recall: Z-2141-2008 · Initiated June 6, 2008

    Recall

    Recall Number
    Z-2141-2008
    Event Number
    48697
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    NIM
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 6, 2008
    Posted
    August 13, 2008
    Terminated
    February 16, 2011
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]

    Reason

    Tip detachment: Boston Scientific has received complaints involving a detachment of the tip from the NexStent Carotid Stent delivery system. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Since the potential for the tip to detach occurs during delivery of the sten

    Action

    Boston Scientific sent an urgent Voluntary Medical Device Recall letter, dated 06/06/08, to affected customers. The letter described the issue, identified affected product, requested to cease using or distributing the product and provided direction on how to return the recalled devices to Boston Scientific, Quincy, MA. A Reply Verification Tracking Form was asked to be returned to Boston Scientific. Since the issue is with the delivery system, patients already implanted with the stent are not affected.

    Distribution

    Worldwide Distribution: USA, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Kuwait, Luxembourg, Netherlands, Norway, Panama, Poland, Portugal, Romania, Spain, Switzerland, and Ukraine.

    Quantity

    1946 units (1570 U.S., 376 OUS)