BEUDAMED
    FDA Recall Terminated

    Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.

    Recall: Z-0262-2018 · Initiated July 28, 2017

    Recall

    Recall Number
    Z-0262-2018
    Event Number
    77797
    Firm
    NXTHERA
    FEI Number
    3007795803
    Product Code
    KNS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 28, 2017
    Terminated
    August 1, 2018
    Address
    7351 Kirkwood Ln N, Maple Grove, MN, 55369-5201

    Description

    Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.

    Reason

    Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.

    Action

    Customers were notified initially by sales representatives on or about July 18, 2017. Any affected devices were to be returned to NxThera. Additionally, a formal recall letter was mailed to customers on approximately July 28, 2017. NxThera's telephone contact information and FEDEX number will be provided on the verification form. For further questions, please call (763) 515-2084..

    Distribution

    USA Distribution to the states of : AL, AZ, CA, CO, FL, GA, IL, MA, MI, MN, MO, NE, NJ, NY, OH, PA, TN, UT, WA.

    Quantity

    113 units total