BEUDAMED
    FDA Recall Terminated

    Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

    Recall: Z-0716-2017 · Initiated October 31, 2016

    Recall

    Recall Number
    Z-0716-2017
    Event Number
    75570
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    LWR
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    October 31, 2016
    Terminated
    November 3, 2017
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    Description

    Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

    Reason

    Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.

    Action

    The firm, LivaNova, sent a "Customer Letter" dated 10/31/2016 to its Consignees with clarifications about the implant of the Perceval Sutureless Aortic Valve. The letter described the product, problem and actions to be taken. The consignees were instructed to reinforce the steps that may influence procedural success and mitigate potential complications and complete and return the Customer Response Form via fax to: LivaNova Canada Corp, Canada at +1 303 895 2335 or email to: [email protected]. If you have additional questions or request of clarifications, please contact your LivaNova representative or Customer Service. For questions regarding this customer letter, please contact your LivaNova sales representative or email: [email protected].

    Distribution

    Worldwide Distribution-US (Nationwide) including states of: MD, ME, MA, NH, NY, NJ, AL, MS, VA, FL, CA, HI, TN, GA, WI, TX, MI, OH, KS, MN, NC, IL, IN, WA MO, PA, NM, and UT and countries of: Austria, Australia, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Jordan, India, Italy, Iran, Islamic Republic of, Ireland, Israel, Korea, Republic of, Kuwait, Luxembourg, Malaysia, Malta, Mexico, Netherland, New Zealand, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South African, Spain, Switzerland, Romania, Russian Federation,Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.

    Quantity

    845 units