BEUDAMED
    FDA Recall Open, Classified

    Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

    Recall: Z-1695-2024 · Initiated February 5, 2024

    Recall

    Recall Number
    Z-1695-2024
    Event Number
    94072
    Firm
    Abbott Medical
    FEI Number
    2017865
    Product Code
    PNJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 5, 2024
    Posted
    April 29, 2024
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

    Reason

    Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

    Action

    On April 3, 2024, Abbott issued a "Urgent Medical Device Correction" to affected consignees via certified mail, email or hand-delivery. Abbott asked consignees to take the following actions: 1. Prophylactic device replacement is NOT recommended. o All currently manufactured LSP112V devices utilize the upgraded firmware. o Following the firmware upgrade, the implanted device will be equivalent to newly manufactured LSP112V devices. 2. As part of follow-up, suggested within 3 months, upgrade the LSP112V firmware. o For most devices, the upgrade will execute automatically when interrogated. If required, contact Technical Services to assist with the upgrade. o If the device presents in MRI or EVVI mode, reprogram the device to the desired mode and settings. 3. Please return a completed Acknowledgement Form and maintain a record of this notice . along with a copy of the completed Acknowledgement Form to ensure effectiveness of the communication. 4. Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. - Complete and submit the report Online: www.fda.gov/medwatch/report.htm - Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/medwatchforms-fda-safety-reporting or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

    Distribution

    US 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, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. OUS: Pending

    Quantity

    10,610 units