BEUDAMED
    FDA Recall Open, Classified

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    Recall: Z-2002-2021 · Initiated June 3, 2021

    Recall

    Recall Number
    Z-2002-2021
    Event Number
    88087
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    NKE
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 3, 2021
    Posted
    July 2, 2021
    Address
    4100 Hamline Ave N, Bldg 3, Saint Paul, MN, 55112-5700

    Description

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    Reason

    Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

    Action

    The firm began notifying its sales representatives on 06/02/2021 by email or hand delivery and followed with notifying the implanting/following physicians and centers on 06/03/2021 by letter. The letter explained the issue and provided recommendations for the physicians. Information is also posted on www.BostonScientific.com/advisory. Patient notification is done by the implanting/following physician.

    Distribution

    Worldwide distribution.

    Quantity

    6377 units