Class 2 Device Recall VITALITY AVT

• Date Initiated by Firm: March 23, 2007
• Date Posted: July 11, 2007
• Recall Status: Terminated on March 02, 2008
• Recall Number: Z-1052-2007
• Recall Event ID: 37769
• PMA Number: P010012
• Product Classification: implantable defibrillator - Product Code NIK
• Product: VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
• Code Information: Model A155, serial numbers: 112541, 112542, 112543, 112544, 112551, 112552, 112553, 112555, 112566, 112602, 112611, 112616, 112619, 112620, 112621, 112623, 112626, 112627, 112628, 112631, 112632, 112633, 112635, 112636, 112640, 112641, 112643, 112645, 112646, 112647, 112648, 112650, 112651, 112652, 112654, 112655, 112656, 112657, 112658, 112661, 112662, 112663, 112664, 112665, 112666, 112672, 112673, 112675, 112679, 112680, 112681, 112682, 112684, 112685, 112686, 112687, 112688, 112691, 112694, 112695, 112696, 112697, 112698, 112699, 112701, 112702, 112703, 112704, 112706, 112708, 112709, 112710, 112713, 112714, 112715, 112716, 112718, 112719, 112721, 112722, 112725, 112729, 112730, 112733, 112735, 112738, 112739, 112740, 112773, 112777, 112778, 112846, 112849, 112850, 112851, 112852, 112853, 112854, 112855, 112856, 112859, 112860, 112861, 112863, 112865, 112892, 113009, 113011, 113078, 113079, 113167, 113184, 113185, 113189, 113196, 113200, 113201, 113202, 113205, 113207, 113209, 113211, 113213, 113215, 113218, 113219, 113220, 113221, 113222, 113226, 113227, 113229, 113230, 113236, 113237, 113238, 113242, 113246, 113251, 113252, 113253, 113255, 113257, 113258, 113260, 113261, 113265, 113266, 113267, 113269, 113272, 113274, 113275, 113282, 113286, 113289, 113293, 113298, 113299, 113302, 113304, 113305, 113307, 113308, 113310, 113311, 113312, 113315, 113316, 113317, 113318, 113319, 113320, 113321, 113322, 113323, 113324, 113326, 113327, 113328, 113329, 113330, 113334, 113335, 113336, 113338, 113339, 113340, 113342, 113343, 113344, 113345, 113346, 113347, 113348, 113351, 113352, 113353, 113360, 113361, 113364, 113368, 113369, 113380, 113381, 113385, 113387, 113389, 113391, 113397, 113398, 113400, 113401, 113412, 113413, 113414, 113415, 113416, 113417, 113418, 113419, 113421, 113422, 113423, 113424, 113425, 113426, 113439, 113442, 113443, 113445, 113446, 113449, 113450, 113451, 113452, 113453, 113454, 113455, 113456, 113458, 113459, 113461, 113463, 113464, 113467, 113468, 113469, 113470, 113471, 113472, 113474, 113476, 113481, 113483, 113484, 113487, 113490, 113491, 113492, 113494, 113495, 113496, 113498, 113499, 113500, 113504, 113505, 113506, 113507, 113508, 113509, 113511, 113512, 113513, 113514, 113515, 113517, 113520, 113521, 113522, 113525, 113527, 113528, 113532, 113534, 113535, 113536, 113537, 113538, 113540, 113543, 113545, 113546, 113547, 113548, 113549, 113550, 113551, 113552, 113553, 113554, 113555, 113556, 113557, 113559, 113560, 113561, 113562, 113564, 113565, 113566, 113577, 113579, 113580, 113583, 113590, 113622, 113625, 113643, 113646, 113647, 113652, 113656, 113662, 113663, 113664, 113665, 113668, 113671, 113692, 113697, 113698, 113702, 113703, 113704, 113705, 113706, 113707, 113708, 113709, 113711, 113713, 113714, 113719, 113724, 113727, 113728, 113730, 113731, 113732, 113734, 113737, 113738, 113740, 113741, 113743, 113744, 113746, 113747, 113749, 113751, 113753, 113754, 113755, 113756, 113757, 113758, 113759, 113760, 113761, 113762, 113763, 113764, 113765, 113767, 113768, 113771, 113772, 113788, 113823, 113826, 113862, 113864, 113865, 113867, 113868, 113869, 113871, 113873, 113875, 113877, 113880, 113882, 113883, 113884, 113887, 113888, 113889, 113890, 113891, 113892, 113894, 113896, 113907, 113916, 113934, 113935, 113936, 113939, 113941, 113943, 113967, 113968, 113970, 113972, 113973, 113974, 113975, 113976, 113978, 113980, 113984, 113985, 113987, 113990, 113992, 113996, 114001, 114002, 114003, 114004, 114005, 114006, 114008, 114009, 114011, 114013, 114019, 114028, 114029, 114032, 114035, 114037, 114038, 114039, 114040, 114047, 114049, 114052, 114053, 114055, 114056, 114057, 114058, 114060, 114065, 114066, 114067, 114068, 114073, 114076, 114077, 114078, 114080, 114081, 114082, 114086, 114087, 114089, 114093, 114103, 114104, 114106, 114107, 114109, 114113, 114118, 114119, 114120, 114121, 114122, 114123, 114126, 114127, 114128, 114133, 114135, 114139, 114140, 114143, 114144, 114145, 114148, 114149, 114150, 114151, 114153, 114155, 114156, 114159, 114160, 114164, 114167, 114172, 114175, 114176, 114179, 114180, 114181, 114182, 114186, 114188, 114194, 114199, 114202, 114203, 114207, 114208, 114211, 114214, 114216, 114217, 114219, 114224, 114226, 114234, 114235, 114241, 114242, 114245, 114248, 114251, 114253, 114258, 114259, 114261, 114266, 114285, 114298, 114301, 114303, 114306, 114325, 114338, 114360, 114419, 114446, 114457, 114465, 114470, 114475, 114476, 114478, 114479, 114491, 114495, 114497, 115043, 115052, 115065, 115070, 115072, 115077, 115078, 115088, 115116, 115120, 115124, 115126, 115132, 115137, 115159, 115208, 115209, 115210, 115211, 115212, 115214, 115215, 115216, 115217, 115218, 115219, 115220, 115221, 115223, 115224, 115225, 115226, 115228, 115229, 115230, 115231, 115232, 115234, 115235, 115236, 115237, 115238, 115239, 115242, 115243, 115244, 115245, 115246, 115248, 115250, 115251, 115252, 115253, 115254, 115255, 115256, 115257, 115258, 115259, 115260, 115262, 115263, 115264, 115267, 115268, 115269, 115270, 115271, 115272, 115274, 115275, 115276, 115277, 115283, 115289, 115290, 115305, 115306, 115310, 115313, 115344, 115347, 115348, 115352, 115370, 115375, 115402, 115410, 115416, 115472, 115488, 115497, 115529, 115539, 115555, 115562, 115616, 115619, 115628, 115639, 115652, 115667, 115671, 115674, 115678, 115679, 115680, 115682, 115686, 115687, 115700, 115703, 115712, 115732, 115733, 115739, 115743, 115754, 115760, 115782, 115795, 115799, 115830, 115859, 115875, 115879, 115977, 116030, 116067, 116069, 116083, 116084, 116087, 116097, 116101.
• Recalling Firm/ Manufacturer: Boston Scientific CRM Corp; 4100 Hamline Ave N; Saint Paul MN 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: Other
• 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: 693
• 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 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 = NIK and Original Applicant = Boston Scientific Corp.