BEUDAMED
    FDA Recall Terminated

    MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.

    Recall: Z-0911-2016 · Initiated February 4, 2016

    Recall

    Recall Number
    Z-0911-2016
    Event Number
    73243
    Firm
    Abbott Vascular
    FEI Number
    2024168
    Product Code
    NKM
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    February 4, 2016
    Posted
    March 7, 2016
    Terminated
    May 12, 2016
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.

    Reason

    Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture.

    Action

    The firm, Abbott Vascular, sent an "URGENT FIELD SAFETY NOTICE/MITRACLIP/CORRECTION" letter dated 2/4/16 to all the customers who received the MitraClip System. The letter described the product, problem and actions to be taken. The Customers are informed that their inventory is acceptable for safe use following the revised IFU steps described in the customer notification letter and that there is no need for the customers to return any product to Abbott Vascular. Customers with questions are instructed to contact their local Abbott Vascular representative.Customers were also instructed complete and return a Training Form/Effectiveness Check via their Abbott Vascular Representative, fax to 1-951-914-5951 or scan and email to [email protected]. The firm is revising the IFU to incorporate the revised procedural steps. A press release dated 2/26/16 will be posted on the firm's website to inform the public that Abbott has initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. Customers with questions or concerns are instructed to contact Abbott Vascular Representative or call Abbott Vascular at (800) 227-9902.

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina Luxembourg Australia Malaysia Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway Colombia Philippines Corrientes Poland Czech Republic Portugal Denmark Egypt Romania Finland Saudi Arabia France Slovenia Germany Spain Greece Sweden Hong Kong Switzerland Hungary Thailand Indonesia Turkey Israel United Arab Emirates Italy United Kingdom Kuwait and Vietnam.

    Quantity

    7,600 units total (2,300 units in US)