BEUDAMED
    FDA Recall Open, Classified

    AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis

    Recall: Z-0427-2021 · Initiated September 24, 2020

    Recall

    Recall Number
    Z-0427-2021
    Event Number
    86562
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    JCW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 24, 2020
    Posted
    November 6, 2020
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291

    Description

    AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis

    Reason

    The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.

    Action

    On September 24, 2020, the firm issued Urgent Medical Device Removal letters to affected customers. Customers were instructed to do the following: 1. If you have affected inventory, immediately discontinue use of and segregate recalled product in a secure location for return to BSC. 2. Complete and return your response form via email or fax immediately. 3. Customers with affected inventory will receive an RGA# after emailing/faxing their form. Please wait to return any product until you receive the RGA#. 4. Return the recalled product to Boston Scientific Corporation.

    Distribution

    Domestic distribution nationwide. Foreign distribution to Argentina Ecuador Lebanon Saudi Arabia Australia Estonia Malaysia Serbia Austria Finland Malta Singapore Bahrain France Mexico Slovenia Belarus Germany Netherlands South Africa Belgium Great Britain New Zealand South Korea Brazil Greece Norway Spain Canada Guatemala Panama Sweden Chile Hong Kong Poland Switzerland China India Portugal Taiwan Colombia Iran Puerto Rico Thailand Costa Rica Ireland Qatar Turkey Croatia Israel Romania United Arab Emirates Czech Republic Italy Russian Fed. Dominican Republic

    Quantity

    24,064