LifeVest:Electrode Belt component of the LifeVest Wearable Defibrillator, Product number 10A0889A01

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, 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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.