Class 2 Device Recall VITALITY and VITALITY 2

• Date Initiated by Firm: June 24, 2006
• Date Posted: September 28, 2006
• Recall Status: Terminated on March 02, 2008
• Recall Number: Z-1299-06
• Recall Event ID: 35754
• PMA Number: P960040S031
• Product Classification: Defibrillators - Product Code LWP
• Product: VITALITY (models 1870, 1871, T125, T127, T135) and VITALITY 2 (models T165, T167, T175, T177). Implantable Cardioverter Defibrillators (ICD). Quantities Distributed by model are as follows: VITALITY model 1870 = 40, model 1871 = 1, model T125 = 613, model T127 = 49, model T135 = 536. VITALITY2 model T165 = 1,994, model T167 = 710, model T175 = 2,010, model T177 = 879.
• Code Information: model 1870, serial numbers: 218995 thru 219012, 219014 thru 219024, 219026 thru 219029, 219035, 219037, 219040 thru 219049, 219051 thru 219056, 219058 thru 219065, 219067, 219070 thru 219074, 219096 thru 219098. model 1871, serial numbers: 107867, 107870 thru 107875, 107881 thru 107885. model T125, serial numbers: 117844 thru 117849, 117851, 117852 thru 117894, 117896 thru 117899, 117901 thru 117 117902, 117903 thru 117956, 117958, 117974, 117975, 117977, 117979, 117980 thru 117994, 117996 thru 118012, 118014 thru 118030, 118032 thru 118039, 118041, 118043 thru 118103, 118109 thru 118116, 118118, 118119, 118121 thru 118144, 118146 thru 118166, 118168 thru 118219, 118221 thru 118234,118236 thru 118253, 118255, 118259, 118260, 118263 thru 118273, 118275 thru 118277, 118279, 118281, 118289, 118291, 118292, 118294 thru 118297, 118304, 118306 thru 118309, 118312, 118316 thru 118318, 118324 thru 118327, 118329, 118332, 118333, 118337, 118339, 118342, 118346, 118357, 118367, 118373, 118382, 118399 thru 118401, 118404 thru 118408, 118415, 118418, 118421, 118437, 118439, 118794 thru 118816, 118818 thru 118821, 118823 thru 118843, 118845, 118849, 118850, 118852 thru 118863, 118869, 118874 thru 118877, 118879 thru 118904, 118906 thru 118950, 118952 thru 118980, 118986, 118988, 118989, 118993, 118995, 118996, 118999, 119002, 119004 thru 119006, 119010 thru 119020, 119022 thru 119041, 119043 thru 119060, 119062 thru 119097, 119099 thru 119107, 119109 thru 119159, 119161, 119162, 119165 thru 119184, 119186, 119188 thru 119203, 119228, 119230. model T127, serial numbers: 103375, 103376, 103379 thru 103381, 103392 thru 103406, 103412 thru 103414, 103416, 103440, 103441, 103443, 103449, 103453, 103455, 103512 thru 103544, 103546 thru 103573, 103575 thru 103596, 103607 thru 103611, 103613 thru 103624, 103626. model T135, serial numbers: 944848 thru 9440851, 944853, 944854, 944856 thru 944866, 944868 thru 944870, 944873 thru 944878, 944881, 944882, 944886 thru 944897, 944899 thru 944908, 944910 thru 944915, 944917, 944919 thru 944924, 944926 thru 944943, 944945, 944947 thru 944953, 944956, 944960 thru 945028, 945031, 945039, 945042 thru 945047, 945049 thru 945066, 945068, 945069, 945071 thru 945134, 945136, 945137, 945140, 945143, 945145 thru 945154, 945156 thru 945159, 945161, 945162, 945165 thru 945169, 945171, 945174, 945200, 945202 thru 945204, 945210, 945226, 945227, 945231, 945233 thru 945235, 945238, 945241, 945245, 945246, 945248, 945266, 945268, 945269, 945300, 945302, 945307, 945310, 945325, 945328, 945329, 945335, 945340, 945343, 945345, 945346, 945402, 945403, 945405, 945407, 945409 thru 945411, 945415 thru 945437, 945442 thru 945468, 945470, 945471, 945475 thru 945489, 945513, 945835 thru 945840, 945842, 945844, 945846 thru 945863, 945865 thru 945874, 945876, 945878, 945879, 945881 thru 945883, 945885 thru 945901, 945903, 945905 thru 945909, 945915 thru 945957, 945959 thru 945990, 945993, 945994, 945996 thru 946002, 946004 thru 946008, 946010, 946012 thru 946014, 946016 thru 946020, 946023 thru 946025, 946027, 946030 thru 946036, 946039 thru 946041, 946043 thru 946048, 946050, 946051, 946053, 946055 thru 946059, 946061 thru 946069, 946071 thru 946077, 946079, 946080, 946083 thru 946092, 946095, 946097 thru 946108, 946110 thru 946114, 946116 thru 946128, 946130 thru 946143, 946145 thru 946152, 946154 thru 946165, 946167, 946170 thru 946181, 946184 thru 946194, 946205 thru 946211, 946215, 946216, 946219, 946220, 946223, 946224, 946226, 946230, 946235 thru 946237, 946240, 946241,946244, 946245, 946249. model T165, serial numbers: 117224 thru 117238, 117240 thru 117263, 117294 thru 117311, 117315, 117317 thru 117362, 117364, 117367, 117368, 117370 thru 117375, 117377 thru 117379, 117381 thru 117390, 117392, 117394, 117396 thru 117399, 117401 thru 117406, 117409 thru 117423, 117425 thru 117446, 117448 thru 117451, 117453 thru 117455, 117457 thru 117471, 117473 thru 117481, 117483, 117485 thru 117500, 117502 thru 117511, 117513 thru 117535, 117542, 117544, 117545, 117549, 117551, 117554 thru 117582, 117584, 117585, 117588, 117589, 117593 thru 117603, 117605 thru 117617, 117620 thru 117640, 117642 thru 117646, 117648 thru 117677, 117680 thru 117691, 117722 thru 117752, 117754, 117757, 117758, 117762 thru 117775, 117777 thru 117787, 117790, 117792 thru 117805, 117807 thru 117867, 117869 thru 117948,117950 thru 117953, 117955 thru 117962, 117964 thru 117969, 117971 thru 118046, 118048 thru 118061, 118063 thru 118076, 118078, 118079, 118081 thru 118214, 118216 thru 118243, 118245 thru 118267, 118272 thru 118274, 118276 thru 118281, 118283, 118285, 118287 thru 118299, 118301 thru 118326, 118329, 118330, 118334, 118335, 118337 thru 118341, 118343 thru 118347, 118349 thru 118351, 118353 thru 118356, 118362, 118367 thru 118372, 118374 thru 118380, 118382 thru 118391, 118410 thru 118432, 118434, 118435, 118437 thru 118441, 118451, 118457, 118463, 118467 thru 118469, 118472, 118474 thru 118481, 118487, 118488, 118495, 118593, 118628, 118635, 118638, 118643, 118644, 118652, 118653, 118660, 118661, 118665, 118667 thru 118669, 118677, 118703, 118733, 118755, 118756, 118761, 118783 thru 118792, 118802, 118816, 118827, 118842, 118862, 118898 thru 118905,118907 thru 118912, 118914 thru 118917, 118953, 118954, 118959 thru 118964, 118966 thru 118972, 118975, 118977, 118981 thru 118989, 118993 thru 118995, 118997, 119125, 119126, 119262, 119278, 119279, 119285, 119386, 119406, 119648, 119728, 120198, 120200, 120203, 120204, 120206, 120207, 120210, 120213, 120216, 120217, 120220 thru 120245, 120247 thru 120264, 120267 thru 120272, 120274, 120275, 120277 thru 120283, 120285 thru 120323, 120325 thru 120335, 120337 thru 120351, 120353 thru 120356, 120358 thru 120365, 120367 thru 120375, 120377 thru 120382, 120384 thru 120390, 120392 thru 120395, 120397 thru 120404, 120406 thru 120439, 120444, 120446 thru 120448, 120450 thru 120454, 120460 thru 120464, 120467, 120470, 120471, 120474, 120475, 120477, 120479 thru 120493, 120496 thru 120500, 120502, 120505 thru 120519, 120521 thru 120547, 120549 thru 120561, 120564, 120565, 120567 thru 120669, 120571, 120572, 120575 thru 120590, 120593 thru 120599, 120602 thru 120614, 120616, 120618 thru 120626, 120628 thru 120639, 120641 thru 120684, 120686 thru 120708, 120710 thru 120716, 120719 thru 120733, 120735 thru 120756, 120758 thru 120760, 120763 thru 120769, 120771 thru 120850, 120852 thru 120864, 120867, 120868, 120870, 120871, 120873, 120875, 120877, 120878, 120883 thru 120885, 120887 thru 120893, 120896 thru 120902, 120905 thru 120907, 120909 thru 120911, 120913 thru 120916, 120918, 120919, 120923, 120925 thru 120927, 120929, 120931 thru 120942, 120945, 120947, 120949, 120951 thru 120963, 120965 thru 120983, 120985, 120986, 120988 thru 121002, 121004 thru 121013, 121015, 121016, 121018 thru 121071, 121073 thru 121075, 121078 thru 121083, 121085 thru 121090, 121093, 121096, 121097, 121099, 121100, 121102 thru 121115, 121117 thru 121137, 121139 thru 121144, 121146, 121147, 121149 thru 121177, 121179 thru 121199, 121201 thru 121213, 121215 thru 121219, 121222 thru 121247, 121249, 121250, 121252 thru 121273, 121275, 121276, 121279 thru 121295, 121297 thru 121336, 121339 thru 121341, 121343, 121344, 121346 thru 121355, 121359 thru 121392, 121394 thru 121418, 121420, 121421, 121423 thru 121429, 121432, 121434, 121436 thru 121461, 121463, 121465, 121469, 121472, 121474, 121475, 121479, 121485, 121488 thru 121492, 121495 thru 121497, 121499, 121500. model T167, serial numbers: 105233 thru 105257, 105259, 105260, 105262 thru 105266, 105269 thru 105271, 105273 thru 105281, 105283 thru 105290, 105297, 105299 thru 105301, 105303 thru 105322, 105324 thru 105342, 105345, 105346, 105348 thru 105361, 105363 thru 105369, 105371, 105373, 105374, 105376, 105378 thru 105386, 105388 thru 105412, 105423 thru 105452, 105454 thru 105463, 105465 thru 105469, 105471 thru 105482, 105533 thru 105538, 105540 thru 105563, 105565, 105567, 105569, 105570, 105573 thru 105575, 105577 thru 105586, 105589 thru 105592, 105594 thru 105602, 105613 thru 105627, 105633 thru 105641, 105654, 105655, 105658, 105662 thru 105 671, 105688 thru 105697, 105858, 105867, 105953, 106117, 106135, 106157, 106178, 106181, 106200 thru 106223, 106225 thru 106236, 106238 thru 106241, 106243 thru 106249, 106251 thru 106253, 106255, 106256, 106258 thru 106265, 106267 thru 106290, 106292 thru 106294, 106296 thru 106299, 106301 thru 106309, 106311 thru 106317, 106319 thru 106339, 106343 thru 106347, 106349 thru 106356, 106358 thru 106399, 106407 thru 106410, 106412 thru 106425, 106427 thru 106429, 106431, 106432, 106435, 106437 thru 106442, 106445 thru 106465, 106467 thru 106488, 106490 thru 106498, 106502 thru 106505, 106507, 106508, 106510, 106512 thru 106515, 106517 thru 106526, 106528 thru 106539, 106541 thru 106549, 106551 thru 106553, 106555 thru 106567, 106574 thru 106606, 106608 thru 106634, 106636 thru 106647, 106649 thru 106672, 106674 thru 106682, 106684 thru 106691, 106693 thru 106696, 106698, 106700 thru 106721, 106723 thru 106739, 106741 thru 106782, 106785, 106786, 106789 thru 106812, 106814 thru 106819, 106821, 106823, 106824, 106826 thru 106830, 106832, 106833, 106835, 106837, 106839 thru 106841, 106843, 106847, 106848, 106850, 106852 thru 106857, 106859, 106860, 106862, 106864, 106865, 106869 thru 106871. model T175, serial numbers: 113976 thru 113995, 114007, 114008, 114010, 114013, 114015, 114026, 114038, 114039, 114048, 114050, 114054, 114055, 114057, 114060 thru 114062, 114065, 114066, 114068 thru 114070, 114075, 114079, 114087, 114088, 114096 thru 114125, 114128, 114132 thru 114151, 114153 thru 114158, 114160, 114162, 114164 thru 114174, 114176 thru 114192, 114193, 114194, 114196 thru 114199, 114201, 114202, 114204 thru 114206, 114208 thru 114210, 114213 thru 114216, 114218 thru 114220, 114225 thru 114230, 114234 thru 114236, 114238 thru 114255, 114257 thru 114264, 114266 thru 114268, 114270 thru 114286, 114288 thru 114322, 114324 thru 114333, 114335 thru 114350, 114352 thru 114357, 114359 thru 114370, 114372 thru 114377, 114380 thru 114388, 114391 thru 114406, 114408 thru 114412, 114414 thru 114426, 114428, 114429, 114431 thru 114455, 114457 thru 114472, 114474 thru 114479, 114481 thru 114485, 114487 thru 114489, 114491 thru 114499, 114508, 114511 thru 114519, 114521 thru 114533, 114535 thru 114538, 114541, 114543 thru 114546, 114549 thru 114551, 114553 thru 114555, 114557, 114559 thru 114601, 114603 thru 114611, 114613 thru 114615, 114617 thru 114631, 114633 thru 114635, 114637 thru 114657, 114659 thru 114663, 114665 thru 114689, 114691 thru 114694, 114696 thru 114728, 114730, 114731, 114733 thru 114737, 114739 thru 114753, 114755 thru 114772, 114774 thru 114816, 114819, 114820, 114822 thru 114824, 114826 thru 114853, 114856 thru 114884, 114886 thru 114892, 114895 thru 114902, 114904, 114906 thru 114915, 114917 thru 114943, 114945 thru 114964, 114966 thru 115002, 115005 thru 115008, 115010 thru 115045, 115051 thru 115069, 115071 thru 115114, 115116 thru 115126, 115128 thru 115132, 115134 thru 115165, 115167 thru 115203, 115205, 115211 thru 115239, 115241 thru 115244, 115251 thru 115258, 115260 thru 115282, 115284, 115285, 115288 thru 115290, 115292, 115294, 115295, 115297, 115298, 115300 thru 115321, 115324, 115325, 115328, 115330, 115332, 115334, 115336 thru 115348, 115350 thru 115355, 115360 thru 115366, 115368 thru 115372, 115374, 115376, 115377, 115381 thru 115385, 115388, 115391 thru 115396, 115398 thru 115420, 115425, 115477 thru 115484, 115486 thru 115495, 115498 thru 115505, 115508, 115510, 115513, 115515, 115517 thru 115520, 115529, 115533, 115535, 115554, 115559, 115577 thru 115580, 115582, 115585, 115587 thru 115591, 115593, 115595, 115597 thru 115605, 115628, 115635 thru 115637, 115639 thru 115642, 115645, 115647 thru 115656, 115659, 115660, 115662 thru 11515 666, 115686, 115727, 115729, 115732, 115733, 115735, 115736, 115738 thru 115740,115743 thru 115745, 115748 thru 115750, 115755, 115757, 115759, 115764, 115766, 115770, 115773, 115774, 115776, 115777, 115781, 115796, 115837 thru 115843, 115845, 115857 thru 115859, 115872 thru 115877, 115880, 115881, 115883 thru 115886, 115888 thru 115891, 115893 thru 115896, 115899 thru 115903, 115906 thru 115911, 115914, 115916, 115918, 115919, 115922 thru 115932, 115934 thru 115936, 115944, 115950, 115953, 115964, 115967, 116002 thru 116007, 116010 thru 116011, 116022, 116024, 116025, 116027 thru 116031, 116042, 116077, 116207, 116210, 116211, 116214, 116320, 116529, 116754, 116764, 116840, 116861, 116897, 117299, 117303 thru 117306, 117308, 117312, 117316, 117317, 117319 thru 117321, 117323, 117336 thru 117347, 117349, 117352, 117355, 117357 thru 117391, 117393 thru 117428, 117430 thru 117471, 117473 thru 117475, 117477, 117480, 117482 thru 117492, 117494 thru 117511, 117513 thru 117521, 117523 thru 117552, 117554 thru 117569, 117571, 117573 thru 117592, 117595 thru 117638, 117641 thru 117650, 117660 thru 117666, 117668 thru 117676, 117678 thru 117685, 117687 thru 117694, 117696 thru 117702, 117704 thru 117752, 117755 thru 117772, 117774 thru 117803, 117805 thru 117811, 117813, 117815 thru 117819, 117821, 117823, 117824, 117826 thru 117832, 117834 thru 117838, 117840 thru 117853, 117855 thru 117869, 117871, 117873 thru 117880, 117886 thru 117891, 117893, 117894, 117897, 117900 thru 117902, 117904, 117905, 117907 thru 117909, 117912, 117913, 117915 thru 117934, 117936 thru 117939, 117941 thru 117943, 117945 thru 117947, 117951 thru 117968, 117970 thru 117979, 117981 thru 118017, 118019 thru 118022, 118024 thru 118036, 118039, 118040, 118042 thru 118046, 118048 thru 118060, 118062, 118064 thru 118130, 118132 thru 118142, 118144, 118145, 118148 thru 118158, 118160 thru 118198, 118200 thru 118231, 118233 thru 118246, 118248 thru 118254, 118256 thru 118286, 118288, 118290 thru 118293, 118295 thru 118344, 118347 thru 118383, 118385 thru 118401, 118403, 118404, 118406 thru 118408, 118410 thru 118427, 118429 thru 118437, 118440 thru 118485, 118487 thru 118503, 118505, 118506, 118508 thru 118510, 118512 thru 118518, 118521, 118525, 118526, 118528, 118530, 118532, 118534 thru 118536, 118540, 118544, 118548, 118552, 118554, 118556, 118602, 118604, 118606, 118607, 118612, 118617 thru 118619, 118636, 118654, 118655. model T177, serial numbers: 105111 thru 105120, 105124 thru 105126, 105128, 105130 thru 105133, 105136 thru 105160, 105171, 105172, 105174, 105179, 105181 thru 105185, 105187 thru 105203, 105205, 105207 thru 105219, 105221 thru 105225, 105251 thru 105267, 105269 thru 105277, 105279 thru 105297, 105299 thru 105306, 105308 thru 105320, 105366 thru 105369, 105371 thru 105385, 105391 thru 105402, 105404, 105407, 105409 thru 105440, 105471 thru 105476, 105478 thru 105484, 105486 thru 105489, 105491 thru 105494, 105496 thru 105500, 105526 thru 105528, 105530 thru 105532, 105534 thru 105538, 105540, 105542 thru 105565, 105576 thru 105615, 105626 thru 105629, 105631 thru 105640, 105661, 105662, 105665, 105666, 105668 thru 105674, 105681 thru 105690, 105765, 105793, 105795, 105830, 105835, 105926, 105963, 106012, 106366, 106401, 106406, 106435, 106436, 106438 thru 106447, 106449 thru 106460, 106462, 106463, 106466, 106467, 106471 thru 106489, 106491, 106492, 106494, 106495, 106498, 106499, 106501, 106502, 106504 thru 106524, 106526 thru 106531, 106533 thru 106539, 106541, 106543 thru 106562, 106565, 106568, 106588, 106589, 106591, 106593, 106596, 106597, 106600 thru 106602, 106608 thru 106626, 106628 thru 106632, 106634, 106639, 106641 thru 106643, 106645 thru 106650, 106654 thru 106656, 106658, 106660 thru 106669, 106673 thru 106715, 106718 thru 106739, 106741 thru 106744, 106746, 106747, 106749, 106750, 106753 thru 106762, 106764 thru 106768, 106770, 106771, 106773, 106776, 106777, 106779 thru 106784, 106786, 106788 thru 106791, 106793 thru 106804, 106806 thru 106823, 106825 thru 106845, 106847 thru 106872, 106875 thru 106877, 106879 thru 106882, 106884 thru 106886, 106888, 106891 thru 106895, 106897 thru 106907, 106909 thru 106921, 106923 thru 106944, 106946, 106947, 106949 thru 106973, 106975 thru 107004, 107007 thru 107038, 107040 thru 107045, 107047 thru 107063, 107065, 107066, 107068 thru 107094, 107096 thru 107129, 107131, 107134, 107135, 107137 thru 107142, 107144 thru 107168, 107170 thru 107201, 107203 thru 107232, 107234 thru 107255, 107257 thru 107262, 107264, 107266 thru 107272, 107275 thru 107287, 107289, 107291 thru 107300, 107302 thru 107309, 107311 thru 107317, 107339.
• Recalling Firm/ Manufacturer: Boston Scientific CRM Corp; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• Manufacturer Reason for Recall: Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion or incorrect sensing in the affected devices.
• FDA Determined Cause: Other
• Action: A Press Release was issued on 06/26/06. An Urgent Medical Device Safety Information & Corrective Action letter, dated 06/23/06 was delivered to physicians describing preliminary information before Guidant has completed its own investigation and finalized patient care recommendations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possible with patients implanted with affected devices.
• Quantity in Commerce: 6,832
• Distribution: Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Micronesia, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela
• 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 = LWP and Original Applicant = BOSTON SCIENTIFIC