BEUDAMED
    FDA Recall Terminated

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    Recall: Z-0488-2021 · Initiated October 23, 2020

    Recall

    Recall Number
    Z-0488-2021
    Event Number
    86618
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    FHW
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 23, 2020
    Terminated
    May 13, 2021
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3431

    Description

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    Reason

    Potential increased occurrence of pump fracture over the lifetime of the device.

    Action

    Required Action Coloplast asks that you please do the following: 1. Immediately move all inventory (purchased directly or that may be stocked as consignment inventory) to quarantine, and return all Titan pump product (as identified in this notification) to Coloplast within 10 business days of receiving this letter. Product return instructions are located at the end of the attached Acknowledgement and Receipt Form. If you have further distributed this product, please notify your customers at once of this recall. 2. Complete the attached Acknowledgement and Receipt Form indicating the quantity that will be returned. If you do not have pumps to return, please denote that on the form. Please ensure you fill in your contact information. 3. Forward the completed form to the Coloplast contact information found at the bottom of the acknowledgement form. If you have further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email [email protected].

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of DK, ES, JP.

    Quantity

    8,962 units