BEUDAMED
    FDA Enforcement Class II Terminated

    UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract

    Recall: Z-0598-2019 · Reported December 19, 2018

    Enforcement

    Recall Number
    Z-0598-2019
    Event ID
    81576
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neotract Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2018
    Initiation Date
    July 6, 2018
    Classification Date
    December 12, 2018
    Termination Date
    December 2, 2020
    Address
    4473 Willow Rd Ste 100, N/A, Pleasanton, CA, 94588-8570, United States

    Description

    UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract

    Reason

    Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.

    Code Info

    Model: AN00141 (US) and AN00142 (OUS); Catalog No.: UL400-4; Lots: P37940, P37943, P37953, P37956, P37965, P37971, P37985, P37988, P37995, P38001, P38013, P38020, P38124, P38132

    Distribution

    US: AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV,

    Quantity

    8,804