Events

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

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Zoll Lifecor Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    37869
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0936-2007
  • Date de mise en oeuvre de l'événement
    2007-04-27
  • Date de publication de l'événement
    2007-06-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52009
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Defibrillator pads - Product Code MVK
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Zoll Lifecor Corporation, 121 Freeport Rd, Pittsburgh PA 15238-3411
  • Source
    USFDA