BEUDAMED
    FDA Enforcement Class II Ongoing

    Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only

    Recall: Z-2429-2024 · Reported July 31, 2024

    Enforcement

    Recall Number
    Z-2429-2024
    Event ID
    94796
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2024
    Initiation Date
    May 22, 2024
    Classification Date
    July 25, 2024
    Address
    6901 Preston Rd, Plano, TX, 75024-2508, United States

    Description

    Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only

    Reason

    Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

    Code Info

    All Serial numbers/UDI:05415067030016/05415067020246

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI, WY and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    5,900 units