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U.S. Department of Health and Human Services

Class 2 Device Recall VITALITY 2 EL

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 Class 2 Recall
VITALITY 2 EL
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Date Posted July 11, 2007
Recall Status1 Terminated on March 02, 2008
Recall Number Z-1055-2007
Recall Event ID 37769
Premarket Approval
PMA Number
P960040
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
Product VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. By using the metallic housing of the pulse generator as an active electrode, combined with the Guidant Endotak two-electrode defibrillation lead, energy is sent via a dual-current pathway from the distal shocking electrode to the proximal electrode and to the pulse generator case. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tacharrhythmias. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 551112-5798 USA.
Code Information Model T167, serial numbers: 101193, 101196, 101238, 101239, 101240, 101241, 101258, 101259, 101261, 101262, 101263, 101264, 101265, 101266, 101267, 101268, 101269, 101270, 101271, 101272, 101273, 101274, 101275, 101276, 101277, 101278, 101279, 101280, 101281, 101284, 101286, 101287, 101288, 101289, 101291, 101292, 101293, 101294, 101296, 101297, 101298, 101299, 101300, 101301, 101313, 101315, 101316, 101319, 101321, 101353, 101354, 101356, 101367, 101368, 101370, 101372, 101373, 101374, 101375, 101376, 101377, 101378, 101379, 101388, 101389, 101390, 101391, 101393, 101394, 101395, 101396, 101398, 101400, 101401, 101406, 101440, 101443, 101446, 101448, 101449, 101450, 101451, 101456, 101457, 101462, 101464, 101465, 101466, 101472, 101474, 101475, 101476, 101479, 101480, 101488, 101489, 101499, 101500, 101501, 101502, 101503, 101504, 101507, 101509, 101510, 101511, 101513, 101514, 101542, 101544, 101545, 101547, 101549, 101550, 101567, 101568, 101569, 101570, 101571, 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104743, 104744, 104745, 104746, 104747, 104748, 104749, 104750, 104751, 104752, 104753, 104754, 104755, 104756, 104757, 104758, 104759, 104760, 104761, 104762, 104763, 104764, 104765, 104766, 104768, 104769, 104770, 104771, 104772, 104773, 104774, 104775, 104776, 104777, 104778, 104780, 104781, 104782, 104783, 104784, 104786, 104787, 104792, 104793, 104794, 104795, 104797, 104798, 104800, 104802, 104803, 104805, 104806, 104809, 104810, 104811, 104812, 104813, 104814, 104815, 104816, 104817, 104818, 104819, 104820, 104822, 104823, 104824, 104826, 104827, 104828, 104829, 104830, 104831, 104832, 104834, 104835, 104836, 104837, 104838, 104840, 104841, 104842, 104844, 104845, 104846, 104847, 104848, 104849, 104851, 104853, 104854, 104855, 104856, 104857, 104858, 104859, 104860, 104861, 104862, 104864, 104865, 104866, 104867, 104868, 104869, 104870, 104871, 104872, 104873, 104874, 104876, 104877, 104878, 104879, 104880, 104881, 104882, 104883, 104884, 104885, 104886, 104887, 104888, 104890, 104891, 104892, 104894, 104895, 104896, 104897, 104898, 104899, 104901, 104902, 104905, 104907, 104908, 104909, 104910, 104911, 104912, 104913, 104914, 104915, 104916, 104917, 104918, 104919, 104920, 104921, 104922, 104923, 104924, 104925, 104926, 104927, 104928, 104929, 104930, 104931, 104932, 104934, 104937, 104938, 104939, 104940, 104941, 104942, 104943, 104944, 104945, 104946, 104947, 104948, 104949, 104951, 104952, 104953, 104954, 104955, 104956, 104957, 104958, 104959, 104960, 104961, 104962, 104963, 104964, 104965, 104966, 104967, 104968, 104969, 104970, 104971, 104972, 104973, 104974, 104975, 104976, 104977, 104978, 104979, 104980, 104981, 104982, 104983, 104984, 104985, 104986, 104987, 104988, 104989, 104990, 104992, 104993, 104994, 104995, 104996, 104997, 104998, 104999, 105000, 105001, 105002, 105003, 105005, 105006, 105007, 105008, 105010, 105012, 105014, 105016, 105017, 105018, 105020, 105022, 105023, 105024, 105025, 105026, 105027, 105028, 105029, 105030, 105031, 105032, 105033, 105034, 105035, 105036, 105037, 105038, 105039, 105040, 105041, 105042, 105043, 105044, 105045, 105046, 105047, 105049, 105050, 105051, 105053, 105054, 105056, 105057, 105058, 105059, 105060, 105061, 105062, 105063, 105064, 105066, 105067, 105068, 105069, 105070, 105071, 105072, 105073, 105074, 105075, 105076, 105078, 105079, 105080, 105081, 105082, 105083, 105084, 105085, 105086, 105087, 105088, 105089, 105091, 105092, 105093, 105094, 105095, 105096, 105097, 105098, 105099, 105100, 105101, 105102, 105103, 105106, 105107, 105108, 105109, 105110, 105111, 105115, 105153, 105154, 105155, 105156, 105157, 105158, 105159, 105160, 105161, 105162, 105163, 105164, 105165, 105166, 105167, 105168, 105169, 105170, 105171, 105172, 105174, 105175, 105176, 105177, 105178, 105180, 105181, 105182, 105183, 105184, 105185, 105186, 105188, 105189, 105190, 105191, 105192, 105193, 105194, 105195, 105196, 105198, 105199, 105200, 105201, 105202, 105205, 105206, 105207, 105208, 105209, 105210, 105211, 105212, 105213, 105214, 105215, 105216, 105217, 105218, 105219, 105220, 105221, 105222, 105223, 105224, 105225, 105227, 105228, 105229, 105230, 105231, 105232, 105233, 105237, 105238, 105241, 105244, 105247, 105248, 105250, 105252, 105255, 105256, 105258, 105259, 105260, 105264, 105268, 105269, 105272, 105274, 105276, 105277, 105281, 105283, 105284, 105286, 105287, 105289, 105291, 105292, 105293, 105295, 105296, 105297, 105298, 105299, 105301, 105302, 105304, 105305, 105306, 105308, 105310, 105313, 105314, 105316, 105317, 105321, 105323, 105327, 105328, 105329, 105330, 105335, 105336, 105338, 105341, 105343, 105345, 105346, 105350, 105351, 105353, 105354, 105355, 105357, 105360, 105361, 105362, 105364, 105365, 105366, 105368, 105371, 105372, 105373, 105376, 105377, 105380, 105381, 105382, 105383, 105385, 105387, 105389, 105390, 105392, 105393, 105397, 105398, 105399, 105401, 105410, 105411, 105412, 105413, 105414, 105415, 105416, 105417, 105418, 105419, 105420, 105421, 105422, 105423, 105424, 105425, 105429, 105431, 105432, 105439, 105440, 105441, 105443, 105444, 105450, 105454, 105455, 105456, 105457, 105458, 105459, 105460, 105461, 105464, 105466, 105469, 105470, 105471, 105473, 105474, 105476, 105477, 105478, 105479, 105481, 105482, 105496, 105497, 105501, 105503, 105504, 105506, 105507, 105508, 105509, 105510, 105511, 105512, 105513, 105514, 105515, 105516, 105517, 105518, 105519, 105520, 105521, 105522, 105525, 105526, 105530, 105533, 105534, 105535, 105537, 105538, 105540, 105541, 105542, 105543, 105544, 105547, 105549, 105551, 105553, 105554, 105555, 105556, 105557, 105559, 105561, 105562, 105564, 105565, 105566, 105567, 105568, 105569, 105572, 105573, 105575, 105576, 105577, 105583, 105584, 105585, 105589, 105590, 105591, 105600, 105601, 105613, 105615, 105619, 105622, 105623, 105625, 105633, 105634, 105635, 105636, 105638, 105639, 105655, 105658, 105659, 105662, 105663, 105665, 105668, 105670, 105671, 105678, 105679, 105680, 105681, 105682, 105690, 105694, 105695, 105728, 105751, 105755, 105810, 105813, 105814, 105815, 105816, 105817, 105818, 105819, 105820, 105821, 105822, 105823, 105824, 105825, 105826, 105827, 105828, 105829, 105830, 105831, 105832, 105847, 105848, 105853, 105854, 105855, 105856, 105857, 105858, 105859, 105860, 105861, 105862, 105863, 105864, 105865, 105866, 105869, 105870, 105871, 105872, 105873, 105875, 105876, 105877, 105878, 105879, 105880, 105881, 105882, 105883, 105884, 105885, 105886, 105887, 105888, 105889, 105890, 105891, 105892, 105893, 105894, 105895, 105896, 105897, 105899, 105900, 105902, 105903, 105904, 105905, 105906, 105907, 105908, 105909, 105910, 105911, 105912, 105913, 105914, 105915, 105916, 105917, 105919, 105920, 105921, 105922, 105923, 105924, 105925, 105926, 105927, 105928, 105929, 105930, 105931, 105932, 105933, 105934, 105936, 105938, 105939, 105940, 105941, 105942, 105943, 105944, 105945, 105946, 105947, 105950, 105951, 105952, 105954, 105955, 105956, 105957, 105959, 105960, 105961, 105963, 105965, 105966, 105967, 105968, 105969, 105970, 105971, 105972, 105973, 105974, 105975, 105976, 105977, 105978, 105979, 105980, 105981, 105982, 105983, 105984, 105985, 105986, 105987, 105988, 105989, 105990, 105992, 105993, 105994, 105995, 105996, 105997, 105998, 105999, 106117, 106181, 106230, 106275, 106276, 106343, 106388, 106391, 106400, 106402, 106403, 106405, 106406, 106411, 106433, 106506, 106509, 106571, 106573, 106783, 106784, 106787, 106788, 116756. Model T177, serial numbers: 101050, 101053, 101068, 101083, 101087, 101089, 101100, 101101, 101102, 101103, 101105, 101106, 101107, 101109, 101110, 101111, 101113, 101114, 101115, 101116, 101117, 101118, 101119, 101120, 101121, 101122, 101123, 101124, 101125, 101127, 101128, 101129, 101130, 101131, 101132, 101133, 101134, 101138, 101147, 101148, 101155, 101166, 101172, 101187, 101219, 101236, 101239, 101290, 101293, 101294, 101296, 101297, 101298, 101299, 101300, 101301, 101303, 101305, 101307, 101308, 101309, 101311, 101312, 101313, 101315, 101318, 101319, 101340, 101343, 101350, 101351, 101352, 101353, 101354, 101356, 101359, 101360, 101361, 101365, 101366, 101367, 101373, 101377, 101453, 101465, 101466, 101467, 101468, 101469, 101472, 101473, 101474, 101475, 101477, 101479, 101481, 101484, 101498, 101499, 101500, 101501, 101505, 101507, 101509, 101510, 101512, 101513, 101514, 101515, 101516, 101517, 101518, 101519, 101546, 101607, 101631, 101700, 101702, 101703, 101709, 101711, 101716, 101717, 101722, 101726, 101728, 101729, 101732, 101733, 101734, 101767, 101768, 101769, 101770, 101854, 101857, 101862, 101863, 101866, 101867, 101868, 101878, 101886, 101887, 101891, 101892, 101893, 101896, 101900, 101901, 101903, 101905, 101906, 101907, 101908, 101909, 101914, 101915, 101916, 101917, 101918, 101920, 101922, 101923, 101924, 101925, 101926, 101927, 101929, 101930, 101932, 101933, 101934, 101938, 101939, 101941, 101942, 101943, 101944, 101945, 101946, 101947, 101969, 101971, 101998, 101999, 102000, 102001, 102002, 102011, 102012, 102013, 102014, 102025, 102031, 102032, 102033, 102034, 102037, 102038, 102041, 102042, 102046, 102049, 102051, 102054, 102056, 102057, 102058, 102059, 102060, 102061, 102063, 102064, 102085, 102086, 102087, 102089, 102091, 102092, 102093, 102094, 102096, 102099, 102100, 102101, 102102, 102103, 102104, 102105, 102106, 102107, 102108, 102109, 102110, 102111, 102112, 102113, 102114, 102115, 102117, 102118, 102119, 102122, 102123, 102124, 102131, 102135, 102154, 102155, 102157, 102159, 102160, 102163, 102165, 102166, 102167, 102168, 102169, 102171, 102172, 102173, 102174, 102175, 102176, 102177, 102178, 102179, 102181, 102182, 102183, 102184, 102185, 102186, 102187, 102188, 102189, 102191, 102196, 102197, 102201, 102203, 102205, 102206, 102207, 102209, 102210, 102211, 102214, 102215, 102216, 102218, 102220, 102222, 102223, 102224, 102225, 102226, 102227, 102230, 102231, 102232, 102233, 102234, 102235, 102236, 102237, 102239, 102240, 102241, 102242, 102243, 102244, 102245, 102246, 102247, 102248, 102251, 102252, 102253, 102254, 102255, 102256, 102258, 102261, 102263, 102264, 102267, 102269, 102271, 102272, 102273, 102274, 102275, 102279, 102281, 102283, 102285, 102286, 102287, 102288, 102289, 102291, 102292, 102294, 102295, 102296, 102297, 102299, 102300, 102301, 102302, 102303, 102308, 102311, 102312, 102317, 102318, 102319, 102320, 102321, 102322, 102323, 102326, 102328, 102329, 102331, 102332, 102333, 102334, 102336, 102338, 102339, 102341, 102342, 102343, 102344, 102345, 102349, 102351, 102355, 102358, 102359, 102360, 102361, 102365, 102373, 102375, 102377, 102378, 102379, 102380, 102382, 102383, 102385, 102387, 102389, 102390, 102391, 102392, 102393, 102394, 102395, 102396, 102397, 102398, 102400, 102401, 102403, 102404, 102405, 102406, 102408, 102409, 102410, 102411, 102412, 102413, 102416, 102418, 102420, 102421, 102422, 102425, 102426, 102427, 102428, 102429, 102457, 102459, 102460, 102462, 102463, 102465, 102467, 102474, 102475, 102478, 102482, 102485, 102486, 102489, 102490, 102491, 102493, 102496, 102497, 102499, 102500, 102501, 102502, 102503, 102505, 102506, 102508, 102509, 102511, 102512, 102513, 102514, 102519, 102524, 102528, 102532, 102537, 102543, 102544, 102546, 102549, 102554, 102575, 102580, 102581, 102582, 102583, 102584, 102585, 102586, 102587, 102588, 102589, 102590, 102591, 102592, 102593, 102595, 102596, 102597, 102598, 102600, 102601, 102602, 102603, 102604, 102605, 102606, 102608, 102622, 102624, 102628, 102630, 102632, 102633, 102638, 102641, 102642, 102643, 102645, 102646, 102648, 102658, 102665, 102666, 102668, 102670, 102671, 102672, 102673, 102674, 102675, 102676, 102677, 102678, 102679, 102680, 102681, 102682, 102683, 102684, 102687, 102689, 102690, 102692, 102693, 102694, 102695, 102696, 102697, 102698, 102699, 102712, 102713, 102714, 102715, 102716, 102717, 102720, 102721, 102723, 102724, 102725, 102726, 102727, 102728, 102729, 102730, 102732, 102733, 102735, 102743, 102751, 102753, 102758, 102767, 102768, 102769, 102770, 102771, 102772, 102775, 102776, 102777, 102778, 102779, 102780, 102781, 102782, 102784, 102800, 102801, 102802, 102803, 102804, 102805, 102807, 102808, 102810, 102813, 102815, 102816, 102817, 102819, 102820, 102821, 102822, 102823, 102825, 102826, 102827, 102828, 102829, 102830, 102831, 102832, 102833, 102834, 102835, 102836, 102840, 102843, 102844, 102846, 102847, 102851, 102852, 102855, 102856, 102858, 102859, 102860, 102861, 102862, 102863, 102864, 102865, 102866, 102867, 102868, 102869, 102870, 102871, 102872, 102873, 102874, 102876, 102877, 102878, 102880, 102882, 102885, 102886, 102890, 102891, 102892, 102894, 102895, 102896, 102899, 102903, 102905, 102906, 102913, 102915, 102937, 102939, 102941, 102942, 102944, 102945, 102947, 102949, 102950, 102951, 102952, 102953, 102954, 102955, 102957, 102959, 102960, 102961, 102962, 102963, 102964, 102965, 102966, 102967, 102968, 102969, 102970, 102971, 102972, 102973, 102974, 102975, 102976, 102982, 102984, 102985, 102990, 102991, 102992, 102993, 102994, 102995, 102997, 103002, 103004, 103008, 103011, 103013, 103015, 103017, 103020, 103021, 103023, 103024, 103026, 103027, 103028, 103029, 103030, 103031, 103032, 103034, 103036, 103037, 103038, 103039, 103040, 103041, 103042, 103043, 103044, 103053, 103058, 103069, 103083, 103088, 103092, 103094, 103098, 103100, 103103, 103104, 103105, 103109, 103110, 103113, 103114, 103115, 103116, 103117, 103119, 103120, 103121, 103122, 103123, 103124, 103125, 103126, 103127, 103128, 103132, 103133, 103134, 103135, 103138, 103139, 103143, 103144, 103145, 103146, 103147, 103148, 103150, 103151, 103152, 103153, 103154, 103155, 103157, 103158, 103160, 103162, 103164, 103174, 103175, 103180, 103181, 103182, 103184, 103186, 103187, 103188, 103189, 103190, 103191, 103194, 103196, 103197, 103198, 103200, 103202, 103204, 103206, 103207, 103211, 103213, 103224, 103229, 103230, 103231, 103232, 103233, 103234, 103239, 103246, 103248, 103261, 103262, 103264, 103265, 103266, 103270, 103272, 103274, 103275, 103276, 103277, 103278, 103279, 103285, 103286, 103290, 103291, 103298, 103302, 103303, 103307, 103309, 103332, 103333, 103334, 103336, 103339, 103340, 103346, 103350, 103351, 103352, 103353, 103354, 103356, 103358, 103365, 103366, 103367, 103371, 103372, 103374, 103375, 103376, 103378, 103392, 103401, 103403, 103406, 103409, 103412, 103414, 103417, 103428, 103429, 103430, 103431, 103433, 103446, 103449, 103455, 103461, 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Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Manufacturer Reason
for Recall
Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
Quantity in Commerce 6,160
Distribution Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CLONMEL LIMITED
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CORP.
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CORPORATION
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CORPORATION (BSC)
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CRV
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC-CRM
PMAs with Product Code = NIK and Applicant = CARDIAC PACEMAKERS, INC.
PMAs with Product Code = NIK and Applicant = GUIDANT CORP.
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