BEUDAMED
    FDA Recall Terminated

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    Recall: Z-1528-2020 · Initiated February 14, 2020

    Recall

    Recall Number
    Z-1528-2020
    Event Number
    85069
    Firm
    Micro Therapeutics Inc, Dba Ev3 Neurovascular
    FEI Number
    3004904811
    Product Code
    OUT
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    February 14, 2020
    Posted
    March 9, 2020
    Terminated
    June 12, 2024
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811

    Description

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    Reason

    Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.

    Action

    On 02/14/20, Medtronic mailed Urgent Medical Device Recall notices to Healthcare Professionals and Risk Managers. They were advised of the following: 1) Do not use any affected product. Remove and quarantine all unused affected products in your inventory. 2) Return the affected products. Medtronic representatives can assist with facilitating the return of affected product and with identifying suitable replacement product. 3) Complete and return the Customer Confirmation Form. In addition, customers were asked to share the communication within their organization, with other organizations where affected devices were transferred, and any other associated organizations that may be impacted. On 09/04/2020, a Safety and Labeling Notification was sent to customers informing them that that Instructions for Use will be supplemented to update the Precaution and Warning statements and the Device Complications section. Medtronic recommends that physician users be attentive to the updated information in the Instructions for Use and include this information in discussions with patients. Further, please share this communication within your organization, with other organizations where these devices have been transferred, and any other associated organizations that may be impacted by this action.

    Distribution

    Worldwide distribution. US nationwide, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Kazakhstan, Korea, Lebanon, Mexico, Netherlands, Norway, Paraguay, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam

    Quantity

    762