Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

Recall details

Manufacturer

Boston Scientific CRM Corp

Distributor

Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.

Lot

Model N106 - Serial numbers: 222276, 222277, 222279, 222280, 222282, 222283, 222286, 222289, 222290, 222291, 222292, 222293, 222295, 222311, 222312, 222314, 222315, 222316, 222318, 222320, 222321, 222324, 222325, 222335, 222338, 222340, 222342, 222343, 222346, 222361, 222363, 222366, 222372, 222374, 222409. Model N107 - Serial numbers: 100278, 100279, 100280, 100281, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100293, 100294, 100295, 100297, 100298, 100299, 100300, 100301, 100303, 100304, 100305, 100306, 100307, 100308, 100309, 100311, 100312, 100314, 100315, 100317, 100318, 100319, 100320, 100321, 100322, 100324, 100325, 100327, 100328, 100329, 100330, 100331, 100333, 100334, 100335, 100336, 100408, 100409, 100410, 100411, 100413, 100414, 100417, 100418, 100419, 100420, 100421, 100422, 100423, 100425, 100426, 100427, 100429, 100430, 100431, 100432, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100441, 100442, 100445, 100446, 100447, 100448, 100449, 100450, 100451, 100453, 100454, 100455, 100456, 100458, 100459, 100460, 100461, 100462, 100463, 100464, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100474, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100482, 100483, 100484, 100485, 100486, 100488, 100489, 100492, 100494, 100495, 100496, 100497, 100498, 100499, 100500, 100501, 100503, 100505, 100506, 100507, 100509, 100518, 100525, 100527, 100531, 100534, 100535, 100536, 100538, 100539, 100540, 100541, 100542, 100543, 100544, 100546, 100547, 100548, 100549, 100550, 100551, 100554, 100555, 100556, 100557, 100558, 100559, 100562, 100563, 100564, 100565, 100566, 100567, 100854, 100855, 100856, 100857, 100858, 100860, 100862, 100863, 100864, 100865, 100866, 100867, 100868, 100869, 100870, 100871, 100872, 100873. Model N108 - Serial numbers: 666667, 666668, 666669, 666670, 666671, 666672, 666673, 666675, 666676, 666677, 666678, 666679, 666680, 666681, 666682, 666683, 666684, 666685, 666686, 666687, 666688, 666689, 666690, 666691, 666693, 666694, 666695, 666696, 666697, 666699, 666700, 666702, 666703, 666704, 666705, 666706, 666707, 666708, 666710, 666711, 666713, 666714, 666715, 666716, 666717, 666718, 666719, 666720, 666721. Model N118 - Serial numbers: , 565136, 565138, 565140, 565146, 565149, 565151, 565152, 565154, 565155, 565157, 565158, 565160, 565163, 565164, 565165, 565167, 565168, 565170, 565173, 565176, 565177, 565178, 565179, 565181, 565182, 565186, 565187, 565188, 565189, 565190, 565191, 565192, 565193, 565194, 565197, 565198, 565199, 565200, 565202, 565204, 565209, 565210, 565319, 565320, 565321, 565326, 565328, 565329, 565330, 565331, 565332, 565334, 565335, 565336, 565337, 565338, 565339, 565342, 565343, 565344, 565345, 565356, 565359, 565363, 565364, 565365, 565367, 565368, 565371, 565374, 565375, 565376, 565378, 565379, 565383, 565384, 565386, 565388, 565390, 565394, 565396, 565397, 565398, 565401, 565402, 565404, 565406, 565407, 565408, 565409, 565410, 565412, 565415, 565416, 565418, 565421, 565427, 565429, 565433, 565434, 565437, 565440, 565441, 565442, 565444, 565446, 565447, 565448, 565449, 565450, 565452, 565454, 565455, 565457, 565460, 565467, 565469, 565471, 565475, 565476, 565478, 565480, 565482, 565483, 565485, 565488, 565489, 565490, 565492, 565494, 565495, 565497, 565501, 565502, 565503, 565508, 565510, 565511, 565513, 565517, 565519, 565523, 565524, 565525, 565529, 565531, 565532, 565535, 565537, 565540, 565542, 565543, 565544, 565545, 565550, 565551, 565555, 565556, 565558, 565562, 565563, 565566, 565567, 565568, 565569, 565570, 565571, 565572, 565573, 565575, 565577, 565579, 565580, 565581, 565583, 565584, 565587, 565589, 565590, 565592, 565594, 565595, 565597, 565598, 565603, 565605, 565606, 565607, 565608, 565610, 565611, 565615, 565622, 565627, 565628, 565629, 565630, 565631, 565632, 565633, 565634, 565637, 565638, 565640, 565643, 565644, 565645, 565646, 565648, 565649, 565650, 565653, 565654, 565656,

Risk classification

Class II

Area (FDA)

device

Country

United States