Cardioverter Defibrillator

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Manufacturers representative
    Medilife s.a.l
  • Source
    RLMPH

78 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model Catalog: D234VRC (Lot serial: CONTACT); Model Catalog: D234VRC (Lot serial: MANUFACTURER); Model Catalog: D234VRC (Lot serial: >100 NUMBERS); Model Catalog: D284DRG (Lot serial: PZM605733); Model Catalog: D284DRG (Lot serial: S/N'S PZM605729 PZM605730); Model Catalog: D284DRG (Lot serial: PZM605731 PZM605732); Model Catalog: D224TRKG (Lot serial: CONTACT); Model Catalog: D234TRK (Lot serial: >1000 NUMBERS); Model Catalog: D224TRKG (Lot serial: >1000 NUMBERS); Model Catalog: D234TRK (Lot serial: CONTACT); Model Catalog: D234TRK (Lot serial: MANUFACTURER); Model Catalog: D224TRKG (Lot serial: MANUFACTURER); Model Catalog: D234DRG (Lot serial: CONTACT); Model Catalog: D234DRG (Lot serial: MANUFACTURER); Model Catalog: D284TRK (Lot serial: S/N'S PZP605283S PZP605282S); Model Catalog: D284TRK (Lot serial: PZP605285S); Model Catalog: D234DRG (Lot serial: >1000 NUMBERS)
  • Product Description
    SECURA VR DIGITAL SINGLE CHAMBER IMPLANTABLE
  • Manufacturer
  • Model / Serial
    Model Catalog: (Lot serial: ); Model Catalog: (Lot serial: 2466 DIFFERENT SERIAL NUMBERS)
  • Product Description
    MAXIMO DR7278
  • Manufacturer
  • Model / Serial
    Model Catalog: D164AWG (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D164VWC (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C174AWK (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    VIRTUOSO DUAL CHAMBER ICD
  • Manufacturer
  • Model / Serial
    Model E030, serial numbers: 504800, 505054, 505073, 506067, 506886, 506961, 507219, 507236, 507255, 507268, 507292, 507304, 507332, 507372, 507381, 507388, 507412, 507424, 507446, 507448, 507449, 507454, 507467, 507527, 507538, 507577, 507594, 507600, 507607, 507614, 507618, 507625, 507728, 507742, 507757, 507785, 507829, 507840, 507882, 507898, 507903, 507904, 507923, 507940, 507943, 507944, 507952, 507960, 507963, 507966, 507984, 508001, 508008, 508059, 508130.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    nationwide within US only (OUS distribution not affected).
  • Product Description
    Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation(VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798. USA.
  • Manufacturer
  • 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
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