BEUDAMED
    FDA Recall Open, Classified

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

    Recall: Z-2403-2021 · Initiated July 13, 2021

    Recall

    Recall Number
    Z-2403-2021
    Event Number
    88447
    Firm
    Micro Therapeutics Inc
    FEI Number
    3004904811
    Product Code
    OUT
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 13, 2021
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811

    Description

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

    Reason

    Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

    Action

    On 07/13/2021, the firm sent via mail courier service an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customer informing them they have received reports of serious injuries and deaths in connection with delivery pushwire fracture at the distal section of the delivery system during use. This recall affects all models of the embolization devices manufactured between April - October 2019, and April - May 2020. Customers are instructed to: 1. Do NOT use any impacted product. Remove and quarantine all unused impacted products in their inventory. 2. Return the impacted products to the Recalling Firm. Their Recalling Firm representative can assist in facilitating the return of product as necessary. If alternative product is needed, their Recalling Firm representative can assist them with identifying suitable replacement product. 3. Complete the attached Customer Confirmation Form, see Attachment 2, and fax it to 1-651-367-7075 to the attention of Neurovascular Quality or email it to [email protected]. 4. Share this communication within their organization, with other organizations where impacted devices may have been transferred, and any other associated organizations that may be impacted by this action. For additional questions and/or assistance, contact the Recalling Firm's Representative or email the Office of Medical Affairs at [email protected].

    Distribution

    U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV O.U.S.: Argentina, Brazil Canada, Chile, Colombia, Ecuador, Mexico, Peru, Austria, Belgium, Canary Island, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Macedonia, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Brunei Darussalam, Egypt, Israel, Jordan, Lebanon, Qatar, Saudi Arabia, Syrian Arab Republic, United Arab Emirates, South Africa, Tunisia, Reunion, China, Hong Kong, Macao, Singapore, Taiwan, Australia, New Zealand, Bangladesh, India, Pakistan, Indonesia, Malaysia, Thailand, Vietnam, Japan, and Republic of Korea.

    Quantity

    16,169 total devices for all model/products