Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoll Lifecor Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37869
  • Event Risk Class
    Class 2
  • Event Number
    Z-0936-2007
  • Event Initiated Date
    2007-04-27
  • Event Date Posted
    2007-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52009
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Defibrillator pads - Product Code MVK
  • Reason
    The electrodes do not properly release conductive gel.
  • 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.

Device

LifeVest:Electrode Belt component of the LifeVest Wearable Defibrillator, Product number 10A0889A01
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • 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.
  • Product Description
    Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.
  • Manufacturer
    Zoll Lifecor Corporation

Manufacturer

Zoll Lifecor Corporation
  • Manufacturer Address
    Zoll Lifecor Corporation, 121 Freeport Rd, Pittsburgh PA 15238-3411
  • Source
    USFDA