BEUDAMED
    FDA Recall 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 · Initiated July 29, 2020

    Recall

    Recall Number
    Z-2984-2020
    Event Number
    86161
    Firm
    Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia Italy
    FEI Number
    3005687633
    Product Code
    LWR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 29, 2020
    Terminated
    May 17, 2021

    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.

    Action

    Letter titled, Urgent Medial Device Removal, Perceval single-use accessory kit models assembly error, HV-SAL-2020-1, dated July 29, 2020 was sent to consignees via 1st class mail (certified return receipt) on July 29th, 2020 Informing the affected customers: o It could be impossible to collapse Perceval Sutureless heart valves (Perceval S and Perceval PLUS) while using specific lots of Perceval single-use accessory kits. The issue potentially affects kits assembled with a specific supplier lot; Actions to be taken by the Physician LivaNova is coordinating the removal and replacement of all potentially affected Perceval single use accessory kit lots in your inventory. Please ensure timely execution of the following actions: 1. Using the list provided in Attachment 1, please check your inventory for potentially affected devices supplied to your facility; 2. All potentially affected devices listed in Attachment 1 and still in inventory should not be used and should be quarantined, pending return of the devices to LivaNova; 3. Please complete and return the Attachment 1 by e-mail to [email protected] to initiate the removal/replacement process of the Perceval single-use accessory kit(s). Your LivaNova Representative will contact you to coordinate replacement of the potentially defective device(s) if they have not already been used. Actions to be taken by the Company 1. Notification of the potentially affected devices removal via letter to inform users of the issue and advise them not to use and quarantine the potentially affected devices immediately; 2. Coordinating and providing information to the user on product replacement.Transmission of this Communication Please ensure that this notice is communicated to all personnel within your organization who need to be aware. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Please report all device-re

    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