BEUDAMED
    FDA Recall Open, Classified

    Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A

    Recall: Z-2283-2026 · Initiated April 30, 2026

    Recall

    Recall Number
    Z-2283-2026
    Event Number
    98916
    Firm
    Advanced Bionics, LLC
    FEI Number
    1000220815
    Product Code
    MCM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 30, 2026
    Posted
    June 1, 2026
    Address
    28515 Westinghouse Pl, Valencia, CA, 91355-1398

    Description

    Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A

    Reason

    Due to incorrect shelf-life expiration date.

    Action

    On 04/30/2026, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that HiRes" Ultra 3D HiFocus MS CI (CI-1601-04) were labeled with an expiration date that exceeded the approved 3 year shelf life for the device. Customers are instructed to: " Please review and correct internal patient records to ensure they accurately reflect the products expiration date. " Reply to this email with your selected responses to the effectiveness questionnaire included below. Contact Advanced Bionics customer service at 1-877-829-0026 to return the affected device and for any questions regarding this Recall.

    Distribution

    U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI.

    Quantity

    36