Class 2 Device Recall LifeVest:Electrode Belt component of the LifeVest Wearable Defibrillator, Product number 10A0889A01

• Date Initiated by Firm: April 27, 2007
• Date Posted: June 15, 2007
• Recall Status: Terminated on March 06, 2008
• Recall Number: Z-0936-2007
• Recall Event ID: 37869
• PMA Number: P010030
• Product Classification: Defibrillator pads - Product Code MVK
• Product: Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Zoll Lifecor Corporation; 121 Freeport Rd; Pittsburgh PA 15238-3411
• For Additional Information Contact: Walt Welch; 412-826-9300
• Manufacturer Reason for Recall: The electrodes do not properly release conductive gel
• FDA Determined Cause: Other
• Action: Patients currently using the product should continue to do so while the product removal is underway. Product replacements will begin with the belts currently in the possession of the sales reps. By replacing these first any new patients will be receiving new or refurbished belts with new Therapy Electrodes that have not been exposed to methanol. As patients complete their use of the LifeVest and return their device to the firm the belt's refurbishment process will include replacement of all 3 Therapy Electrodes. The firm expects this process to be completed in approximately 3 months based on the average use of time and current production capabilities. The process may take an additional month for devices distributed overseas. Physicians with active patients were notified via letter sent certified mail on 5/3/07. Long term use patients (patients using the device longer than 3 months) will be notified of the product removal via telephone and follow up letter. Each long term patient will be provided with a replacement belt. They will be instructed to return their existing belt in the same shipping box. Due to the low residual risk no notification is planned for short term use patients. Prescribing physicians have the option to notify their patients if they choose to do so.
• Quantity in Commerce: 944 belts
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MVK and Original Applicant = ZOLL MANUFACTURING CORPORATION