Boston Scientific CRM Corp: 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.

Recall number

Z-1052-2007

Recalling firm

Boston Scientific CRM Corp

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.

Status

Terminated

Initiated

2007-03-23

Posted

2007-07-11

Terminated

2008-03-02

Reason

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.

Root 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

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P010012"]

Product code

NIK

Firm FEI

2124215

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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