Device Recall VITALITY Implantable Cardioverter Defibrillator

  • Model / Serial
    The device serial numbers are only provided for devices subject to the retrieval. For model number with no serial numbers there were no non-implanted devices with domestic customers. Once the required BSC submissions and FDA reviews are completed, the BSCs distribution and implant restrictions will no longer apply.  Model T127, no serial numbers will be retrieved.  Model A155, serial numbers 117091, 117093  Model T125, serial numbers: 124969, 125087, 125099, 125113, 125134, 125231, 125244, 125266, 125293, 125327, 125337, 125349, 125352, 125357, 125362, 125366, 125380, 125382, 125395, 125396, 125418, 125428, 125430.  Model T135, serial numbers: 948527, 949918, 950739, 950750, 950765, 950768, 950774, 950781, 950795, 950824, 950838, 950851, 950852, 950868, 950869, 950870, 950871, 950881, 950893, 950895, 950902.  Model T165, serial numbers: 140004, 140008, 141750, 141752, 142959, 143653, 146287, 146318, 146333, 146345, 146379, 146386, 146419, 146424, 146483, 146492, 146514, 146564, 146743, 146764, 146881, 146893, 146901, 147009, 147044, 147161, 147179, 147193, 147310, 147417, 147450, 147461, 147464, 147507, 147515, 147553, 147554, 147555, 147560, 147568, 147675, 147693, 147695, 147704, 147706, 147724.  Model T167, serial numbers: 115638, 116948, 117036, 117236, 117249, 117251, 117254, 117256, 117257, 118293, 118295.  Model T175, serial numbers: 133117, 138081, 138506, 138630, 138657, 138672, 138676, 138834, 138842, 138904, 138935, 139150, 139157, 139179, 139246, 139299, 139336, 139353, 139850, 139979, 139998, 140016, 140017, 140022, 140217, 140243, 140331, 140340.  Model T177, serial numbers: 116495, 116872, 117635, 117758, 117800, 117814, 117821, 118308, 118318, 118321, 118326, 118329, 118330.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    nationwide within US only (OUS distribution not affected).
  • Product Description
    VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. AVT, model A155. VITALITY DS DR/VR (Models T125, T135), VITALITY 2 DR/VR (Models T165, T175) and VITALITY 2 EL DR/VR (Models T167, T177) Implantable Cardioverter Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA