BEUDAMED
    FDA Recall Open, Classified

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    Recall: Z-0753-2025 · Initiated November 21, 2024

    Recall

    Recall Number
    Z-0753-2025
    Event Number
    95813
    Firm
    Abbott Medical
    FEI Number
    2017865
    Product Code
    PNJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 21, 2024
    Posted
    December 23, 2024
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    Reason

    Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

    Action

    On 11/21/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via in person or certified mail to customers informing them that Abbott is aware of a programmer software anomaly that may incorrectly reprogram a ventricular Aveir leadless pacer during the Finalize the New LP ( Finalization ) step of the implant process for an AVEIR DR Leadless Pacemaker (LP) System. This can occur during an upgrade from an AVEIR VR to an AVEIR DR system or during a new AVEIR DR system implant. If telemetry is lost during a small window (<2 seconds) during Finalization of the Right Atrial (RA) LP after the Right Ventricular (RV) LP is Finalized, the programmer software anomaly configures the RV LP to incorrectly behave as an RA LP. If this occurs, the Merlin PCS 3650 Programmer displays a Loss of telemetry detected window, and there is no pacing. Additionally, atrial sense markers coincident to intrinsic QRS complexes may be observed. Subsequent attempts to finalize the device will continue to result in a Loss of telemetry detected window. In all cases where this occurred, full functionality, including ability to finalize the device and restore pacing, was reinstated through Abbott Technical Services intervention. Action Abbott has Taken: Currently available Merlin" PCS 3650 programmer software (version 28.2.1 rev 2) prevents this issue. An Abbott Representative will upgrade your programmer software and work with customer to ensure use of version 28.2.1 rev 2 or greater as it eliminates this issue. A list of Abbott advisories is available at https://www.cardiovascular.abbott/us/en/hcp/product-advisories.html. any questions about this notice, contact Abbott Technical Services at 1-800-722-3774 (U.S.).

    Distribution

    Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN TX, UT, VA, WA, WI, and WV. The countries of Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

    Quantity

    7295 programmers