BEUDAMED
    FDA Enforcement Class II Terminated

    Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.

    Recall: Z-2984-2020 · Reported September 30, 2020

    Enforcement

    Recall Number
    Z-2984-2020
    Event ID
    86161
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group Italia S.r.l.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2020
    Initiation Date
    July 29, 2020
    Classification Date
    September 18, 2020
    Termination Date
    May 17, 2021
    Address
    Via Crescentino Sn, N/A, Saluggia, N/A, N/A, Italy

    Description

    Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.

    Reason

    LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.

    Code Info

    Kit Lots: 2002060216, 2002060218

    Distribution

    US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA, WA, WI and the countries of Canada, Japan, Germany, Netherland, Switzerland, Sweden, UK, Spain, Italy, France, Belgium, Finland, Greece, Slovenia, Malta, Poland, Romania, Croatia, Hungary, Serbia, Australia, Israel, Georgia, Iran, Kuwait, Oman, Quatar, Singapore, Thailand, Taiwan, Russia, South Africa.

    Quantity

    77 kits