LifeVest Wearable Defibrillator

Medical electronics / Electromedical devices

Product number 10A0889-A01. Serial numbers with active patients: 79000004, 79000055, 79000064, 79000073, 79000106, 79000157, 79000181, 79000205, 79000208, 79000217, 79000226, 79000238, 79000244, 79000259, 79000274, 79000277, 79000286, 79000289, 79000298, 79000328, 79000346, 79000358, 79000364, 79000367, 79000373, 79000376, 79000379, 79000388, 79000403, 79000409, 79000445, 79000454, 79000457, 79000466, 79000487, 79000490, 79000493, 79000508, 79000511, 79000529, 79000532, 79000547, 79000556, 79000562, 79000574, 79000577, 79000595, 79000598, 79000601, 79000604, 79000616, 79000631, 79000634, 79000637, 79000640, 79000652, 79000661, 79000670, 79000686, 79000685, 79000694, 79000697, 79000715, 79000727, 79000730, 79000739, 79000754, 79000760, 79000769, 79000790, 79000796, 79000799, 79000802, 79000811, 79000823, 79000829, 79000832, 79000835, 79000838, 79000841, 79000844, 79000847, 79000853, 79000856, 79000886, 79000889, 79000901, 79000904, 79000925, 79000931, 79000934, 79000937, 79000943, 79000958, 79000973, 79000979, 79000982, 79000994, 79001003, 79001018, 79001021, 79001024, 79001027, 79001030, 79001033, 79001036, 79001042, 79001048, 79001054, 79001060, 79001066, 79001078, 79001081, 79001093, 79001099, 79001102, 79001111, 79001117, 79001147, 79001150, 79001153, 79001156, 79001162, 79001198, 79001201, 79001207, 79001216, 79001219, 79001228, 79001237, 79001243, 79001255, 79001273, 79001276, 79001288, 79001300, 79001318, 79001339, 79001354, 79001357, 79001363, 79001369, 79001372, 79001375, 79001378,79001384, 79001387, 79001399, 79001402, 79001405, 79001408, 79001417, 79001423, 79001429, 79001441, 79001444, 79001456, 79001459, 79001462, 79001468, 79001486, 79001492, 79001498, 79001501, 79001504, 79001522, 79001525, 79001528, 79001534, 79001537, 79001540, 79001558, 79001564, 79001570, 79001573, 79001582, 79001585, 79001588, 79001594, 79001597, 79001603, 79001630 79001639, 79001642, 79001648, 79001654, 79001657, 79001660, 79001666, 79001672, 79001675, 79001681, 79001690, 79001693, 79001699, 79001714, 79001717, 79001732, 79001738, 79001741, 79001744, 79001750, 79001753, 79001756, 79001759, 79001762, 79001765, 79001771, 79001777, 79001780, 79001786, 79001795, 79001798, 79001801, 79001804, 79001810, 79001822, 79001834, 79001837, 79001840, 79001846, 79001849, 79001852, 79001867, 79001879, 79001882, 79001906, 79001912, 79001918, 79001924, 79001939, 79001942, 79001945, 79001954, 79001957, 79001963, 79001969, 79001984, 79001996, 79002002, 79002005, 79002011, 79002017, 79002026, 79002041, 79002044, 79002047, 79002053, 79002056, 79002059, 79002068, 79002071, 79002074, 79002089, 79002110, 79002116, 79002119, 79002122, 79002128, 79002140, 79002152, 79002155, 79002164, 79002170, 79002176, 79002179, 79002182, 79002185, 79002191, 79002194, 79002200, 79002206, 79002215, 79002218, 79002221, 79002224, 79002227, 79002233, 79002236, 79002248, 79002251, 79002263, 79002275, 79002278, 79002287, 79002290, 79002293, 79002305, 79002308, 79002320, 79002329, 79002332, 79002338, 79002347, 79002359, 79002368, 79002377, 79002392, 79002404, 79002413, 79002416, 79002422, 79002425, 79002428, 79002440, 79002446, 79002449, 79002452, 79002455, 79002458, 79002479, 79002482, 79002494, 79002497, 79002509, 79002512, 79002521, 79002524, 79002530, 79002533, 79002539, 79002554, 79002560, 79002563, 79002566, 79002578, 79002587, 79002593, 79002602, 79002605, 79002608, 79002617, 79002620, 79002623, 79002629, 79002635, 79002644, 79002647, 79002650, 79002659, 79002665, 79002671, 79002674, 79002677, 79002698, 79002701, 79002710, 79002728, 79002740, 79002749, 79002761, 79002764, 79002767, 79002770, 79002776, 79002779, 79002782, 79002785, 79002788, 79002794, 79002800, 79002806, 79002818, 79002827, 79002833, 79002842, 79002848, 79002860, 79002863, 79002866, 79002869, 79002875, 79002878, 79002881, 79002884, 79002896, 79002899, 79002902, 79002911, 79002917, 79002932, 79002938, 79002941, 79002950, 79002962, 79002965, 79002968, 79002971, 79002974, 79002977, 79002980, 79002983, 79002989, 79002992, 79003007, 79003010, 79003016, 79003019, 79003028, 79003031, 79003034, 79003037, 79003049, 79003052, 79003055, 79003058, 79003067, 79003070, 79003079, 79003082, 79003088, 79003097, 79003103, 79003118, 79003121, 79003130, 79003133, 79003136, 79003142, 79003151, 79003157, 79003166, 79003172, 79003175, 79003178, 79003190, 79003196, 79003199, 79003205, 79003211, 79003223, 79003229, 79003235, 79003244, 79003262, 79003265, 79003274, 79003277, 79003295, 79003316, 79003325, 79003328, 79003331, 79003346, 79003349, 79003373, 79003382, 79003400, 79003415, 79003445, 79003454, 79003457, 79003460, 79003463, 79003469, 79003472, 79003478, 79003493, 79003508, 79003511, 79003520, 79003526, 79003529, 79003538, 79003544, 79003550, 79003553, 79003556, 79003568, 79003583, 79003589, 79003592, 79003598, 79003601, 79003604, 79003607, 79003613, 79003616, 79003628, 79003631, 79003634, 79003637, 79003640, 79003646, 79003649, 79003652, 79003658, 79003661, 79003664, 79003670, 79003673, 79003697, 79003700, 79003703, 79003706, 79003715, 79003718, 79003721, 79003727, 79003730, 79003748, 79003757, 79003760, 79003763, 79003766, 79003769, 79003778, 79003784, 79003793, 79003796, 79003808, 79003823, 79003835, 79003838, 79003841, 79003844, 79003847, 79003850, 79003856, 79003862, 79003868, 79003871, 79003877, 79003889, 79003916, 79003919, 79003922, 79003949, 79003958, 79003961, 79003967, 79003976, 79003985, 79003988, 79004000, 79004003, 79004012, 79004021, 79004027, 79004042, 79004066, 79004078, 79004087, 79004096, 79004108, 79004117, 79004120, 79004126, 79004129, 79004135, 79004141, 79004144, 79004153, 79004162, 79004165, 79004210, and 79004216. Foreign serial numbers with active patients: 79000118, 79000724, 79000736, 79000343, 79000664, 79001075, 79001213, 79000310, 79000394, 79000139, 79000187, 79001231, 79001600, 79000256, 79000370, 79000463, 79000514, 79000592, 79000703, 79000745, 79000766, 79000808, 79001090, 79001171, 79001177, 79001315, 79001336, 79001345, 79001351, 79001390, 79001615, 79001825, 79001870, 79001900, 79001960, 79001966, 79002008, 79002062, 79002149, 79002203, 79002230, 79002272, 79002398, 79002464, 79002488, 79002491, 79002500, 79002545, 79002551, 79002584, 79002590, 79002611, 79002614, 79002680, 79002812, 79002953, 79003013, 79003022, 79003025, 79003094, 79003100, 79003124, 79003127, 79003139, 79003232, 79003247, 79003319, and 79003355. Serial numbers still under the firm''s control: 79000058, 79000190, 79000196, 79000211, 79000214, 79000241, 79000247, 79000253, 79000283, 79000325, 79000334, 79000340, 79000352, 79000391, 79000427, 79000439, 79000448, 79000475, 79000541, 79000544, 79000589, 79000643, 79000667, 79000712, 79000721, 79000772, 79000781, 79000784, 79000793, 79000814, 79000826, 79000850, 79000859, 79000862, 79000865, 79000874, 79000880, 79000895, 79000910, 79000913, 79000952, 79000961, 79000964, 79000985, 79000988, 79001012, 79001063, 79001072, 79001105, 79001120, 79001123, 79001138, 79001180, 79001225, 79001240, 79001252, 79001282, 79001291, 79001297, 79001303, 79001309, 79001312, 79001321, 79001324, 79001333, 79001360, 79001396, 79001420, 79001471, 79001489, 79001507, 79001546, 79001579, 79001591, 79001612, 79001621, 79001702, 79001723, 79001729, 79001792, 79001819, 79001828, 79001855, 79001861, 79001888, 79001903, 79001909, 79001927, 79001933, 79001951, 79001975, 79001981, 79001990, 79002032, 79002035, 79002038, 79002050, 79002065, 79002092, 79002095, 79002101, 79002125, 79002131, 79002134, 79002143, 79002146, 79002158, 79002173, 79002209, 79002245, 79002257, 79002269, 79002281, 79002302, 79002311, 79002314, 79002326, 79002350, 79002356, 79002395, 79002401, 79002410, 79002419, 79002434, 79002461, 79002470, 79002476, 79002569, 79002572, 79002575, 79002581, 79002596, 79002599, 79002632, 79002662, 79002683, 79002686, 79002692, 79002704, 79002713, 79002734, 79002743, 79002746, 79002773, 79002791, 79002803, 79002845, 79002851, 79002857, 79002893, 79002908, 79002923, 79002929, 79002935, 79002956, 79003019, 79003046, 79003085, 79003112, 79003148, 79003154, 79003160, 79003163, 79003169, 79003184, 79003187, 79003193, 79003214, 79003217, 79003226, 79003238, 79003241, 79003250, 79003253, 79003298, 79003301, 79003313, 79003322, 79003334, 79003340, 79003352, 79003379, 79003475, 79003481, 79003490, 79003496, 79003514, 79003541, 79003547, 79003571, 79003574, 79003577, 79003586, 79003643, 79003709, 79003724, 79003742, 79003751, 79003787, 79003790, 79003805, 79003814, 79003817, 79003832, 79003859, 79003865, 79003874, 79003892, 79003895, 79003904, 79003913, 79003925, 79003937, 79003940, 79003943, 79003952, 79003994, 79004006, 79004009, 79004030, 79004033, 79004036, 79004039, 79004045, 79004048, 79004063, 79004069, 79004072, 79004090, 79004093, 79004099, 79004102, 79004105, 79004111, 79004114, 79004132, 79004138, 79004147, 79004156, 79004159, 79004183, 79004186, 79004201, 79004204, 79004207, and 79004240. Foreign serial numbers still under the firm''s control: 79000361, 79000817, 79001132, 79001915, 79000499, 79000868, 79000898, 79001009, 79001414, 79001432, 79002284, 79003004, 79001258, 79001264, 79001279, 79001234, 79001249, 79000187, 79000559, 79001381, 79000265, 79000292, 79000349, 79000406, 79000424, 79000469, 79000520, 79000565, 79000625, 79000649, 79000673, 79000691, 79000877, 79001039, 79001087, 79001435, 79001474, 79001495, 79001513, 79001567, 79001606, 79001609, 79001774, 79001885, 79001930, 79001948, 79002020, 79002299, 79002365, 79002443, 79002503, 79002506, 79002668, 79002689, 79002755, 79002986, 32687900, 79003292, 79003310, 79003337, 79003358, 79003364, 79003403, 79003406, 79003409, and 79003412.

Cardiovascular Devices

3

No

Worldwide: The product was shipped to patients in AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV. The product was also shipped to Germany, United Kingdom, Italy, Spain, France, and Denmark.

Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.

product number 10A0988-A01; Serial number: 07000178, 07000196, 07000199, 07000202, 07000205, 07000211, 07000214, 07000223, 07000232, 07000241, 07000250, 07000265, 07000271, 07000289, 07000298, 07000301, 07000304, 07000307, 07000310, 07000313, 07000316, 07000325, 07000337, 07000343, 07000349, 07000355, 07000361, 07000373, 07000388, 07000397, 07000400, 07000409, 07000415, 07000427, 07000433, 07000436,  07000439, 07000448, 07000463, 07000466, 07000469, 07000472, 07000490, 07000496, 07000505, 07000511, 07000517, 07000520, 07000526, 07000529, 07000532, 07000538, 07000541, 07000574, 07000604, 07000628, 07000637, 07000646, 07000655, 07000658, 07000661, 07000697, 07000721, 07000730, 07000766, 07000769,  07000772, 07000784, 07000793, 07000796, 07000805, 07000808, 07000811, 07000820, 07000826, 07000838, 07000847, 07000853, 07000862, 07000877, 07000880, 07000883, 07000895, 07000898, 07000904, 07000913, 07000916, 07000919, 07000928, 07000937, 07000940, 07000943, 07000946, 07000955, 07000958, 07000976,  07000979, 07001006, 07001012, 07001018, 07001021, 07001024, 07001027, 07001030, 07001039, 07001042, 07001045, 07001066, 07001069, 07001072, 07001075, 07001081, 07001084, 07001087, 07001090, 07001105, 07001108, 07001111, 07001117, 07001120, 07001123, 07001126, 07001132, 07001138, 07001144, 07001147,  07001150, 07001153, 07001171, 07001174, 07001177, 07001180, 07001186, 07001195, 07001201, 07001204, 07001210, 07001216, 07001222, 07001225, 07001231, 07001234, 07001240, 07001243, 07001255, 07001270, 07001273, 07001285, 07001288, 07001291, 07001300, 07001303, 07001312, 07001315, 07001321, 07001324,  07001330, 07001333, 07001348, 07001360, 07001378, 07001381, 07001384, 07001387, 07001393, 07001396, 07001411, 07001414, 07001417, 07001423, 07001426, 07001432, 07001438, 07001441, 07001447, 07001450, 07001456, 07001462, 07001465, 07001483, 07001486, 07001492, 07001498, 07001510, 07001513, 07001525,  07001534, 07001543, 07001552, 07001564, 07001582, 07001594, 07001603, 07001606, 07001609, 07001615, 07001618, 07001624, 07001627, 07001630, 07001633, 07001636, 07001645, 07001648, 07001690, 07001696, 07001699, 07001702, 07001705, 07001708, 07001720, 07001723, 07001726, 07001735, 07001750, 07001753,  07001768, 07001780, 07001789, 07001804, 07001810, 07001813, 07001816, 07001828, 07001834, 07001837, 07001840, 07001843, 07001852, 07001855, 07001858, 07001861, 07001867, 07001870, 07001873, 07001879, 07001882, 07001885, 07001891, 07001897, 07001921, 07001924, 07001936, 07001942, 07001945, 07001951,  07001954, 07001957, 07001960, 07001963, 07001978, 07001981, 07001984, 07001999, 07002002, 07002008, 07002020, 07002032, 07002035, 07002047, 07002050, 07002071, 07002074, 07002077, 07002086, 07002089, 07002104, 07002110, 07002113, 07002119, 07002125, 07002134, 07002146, 07002149, 07002158, 07002167,  07002170, 07002173, 07002176, 07002179, 07002182, 07002185, 07002188, 07002191, 07002200, 07002212, 07002215, 07002227, 07002248, 07002251, 07002263, 07002266, 07002272, 07002278, 07002281, 07002287, 07002293, 07002299, 07002305, 07002308, 07002314, 07002317, 07002320, 07002329, 07002338, 07002344,  07002356, 07002365, 07002368, 07002380, 07002389, 07002392, 07002401, 07002413, 07002416, 07002428, 07002431, 07002437, 07002449, 07002455, 07002461, 07002467, 07002470, 07002473, 07002482, 07002488, 07002491, 07002494, 07002503, 07002512, 07002518, 07002524, 07002527, 07002530, 07002545, 07002548,  07002551, 07002554, 07002557, 07002563, 07002572, 07002575, 07002581, 07002593, 07002599, 07002602, 07002605, 07002611, 07002614, 07002623, 07002626, 07002629, 07002632, 07002650, 07002656, 07002659, 07002668, 07002671, 07002680, 07002683, 07002689, 07002692, 07002704, 07002707, 07002713, 07002722,  07002725, 07002728, 07002731, 07002752, 07002767, 07002776, 07002779, 07002785, 07002788, 07002791, 07002794, 07002800, 07002812, 07002815, 07002818, 07002821, 07002842, 07002845, 07002854, 07002857, 07002866, 07002869, 07002872, 07002875, 07002878, 07002881, 07002884, 07002899, 07002902, 07002905,  07002914, 07002929, 07002932, 07002935, 07002938, 07002941, 07002944, 07002950, 07002953, 07002962, 07002965, 07002968, 07002974, 07002983, 07002998, 07003004, 07003007, 07003010, 07003016, 07003022, 07003025, 07003028, 07003031, 07003043, 07003064, 07003070, 07003076, 07003079, 07003085, 07003088,  07003097, 07003106, 07003109, 07003112, 07003115, 07003118, 07003121, 07003133, 07003136, 07003142, 07003145, 07003151, 07003154, 07003157, 07003166, 07003169, 07003172, 07003175, 07003178, 07003184, 07003190, 07003193, 07003196, 07003199, 07003202, 07003205, 07003208, 07003211, 07003217, 07003220,  07003223, 07003238, 07003241, 07003253, 07003259, 07003268, 07003274, 07003280, 07003283, 07003292, 07003298, 07003301, 07003304, 07003310, 07003319, 07003322, 07003325, 07003328, 07003334, 07003337, 07003343, 07003352, 07003355, 07003361, 07003367, 07003370, 07003385, 07003391, 07003394, 07003400,  07003406, 07003409, 07003415, 07003424, 07003427, 07003430, 07003433, 07003460,

Cardiovascular Devices

3

No

Nationwide Distribution: Throughout the US. including the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV.

Model 4000 Monitor component of the LifeVest Wearable Defibrillator