Device Recall VITALITY AVT

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • 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.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA