“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.”
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.
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.