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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69291

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 17, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boston Scientific CRM Corp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

Z-0087-2015
Recall number
Z-0087-2015
Initiated
September 17, 2014
Classification
Class II
Status
Terminated
Quantity
31,144 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt

Code information

Model N106 - Serial numbers: 222276, 222277, 222279, 222280, 222282, 222283, 222286, 222289, 222290, 222291, 222292, 222293, 222295, 222311, 222312, 222314, 222315, 222316, 222318, 222320, 222321, 222324, 222325, 222335, 222338, 222340, 222342, 222343, 222346, 222361, 222363, 222366, 222372, 222374, 222409. Model N107 - Serial numbers: 100278, 100279, 100280, 100281, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100293, 100294, 100295, 100297, 100298, 100299, 100300, 100301, 100303, 100304, 100305, 100306, 100307, 100308, 100309, 100311, 100312, 100314, 100315, 100317, 100318, 100319, 100320, 100321, 100322, 100324, 100325, 100327, 100328, 100329, 100330, 100331, 100333, 100334, 100335, 100336, 100408, 100409, 100410, 100411, 100413, 100414, 100417, 100418, 100419, 100420, 100421, 100422, 100423, 100425, 100426, 100427, 100429, 100430, 100431, 100432, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100441, 100442, 100445, 100446, 100447, 100448, 100449, 100450, 100451, 100453, 100454, 100455, 100456, 100458, 100459, 100460, 100461, 100462, 100463, 100464, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100474, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100482, 100483, 100484, 100485, 100486, 100488, 100489, 100492, 100494, 100495, 100496, 100497, 100498, 100499, 100500, 100501, 100503, 100505, 100506, 100507, 100509, 100518, 100525, 100527, 100531, 100534, 100535, 100536, 100538, 100539, 100540, 100541, 100542, 100543, 100544, 100546, 100547, 100548, 100549, 100550, 100551, 100554, 100555, 100556, 100557, 100558, 100559, 100562, 100563, 100564, 100565, 100566, 100567, 100854, 100855, 100856, 100857, 100858, 100860, 100862, 100863, 100864, 100865, 100866, 100867, 100868, 100869, 100870, 100871, 100872, 100873. Model N108 - Serial numbers: 666667, 666668, 666669, 666670, 666671, 666672, 666673, 666675, 666676, 666677, 666678, 666679, 666680, 666681, 666682, 666683, 666684, 666685, 666686, 666687, 666688, 666689, 666690, 666691, 666693, 666694, 666695, 666696, 666697, 666699, 666700, 666702, 666703, 666704, 666705, 666706, 666707, 666708, 666710, 666711, 666713, 666714, 666715, 666716, 666717, 666718, 666719, 666720, 666721. Model N118 - Serial numbers: , 565136, 565138, 565140, 565146, 565149, 565151, 565152, 565154, 565155, 565157, 565158, 565160, 565163, 565164, 565165, 565167, 565168, 565170, 565173, 565176, 565177, 565178, 565179, 565181, 565182, 565186, 565187, 565188, 565189, 565190, 565191, 565192, 565193, 565194, 565197, 565198, 565199, 565200, 565202, 565204, 565209, 565210, 565319, 565320, 565321, 565326, 565328, 565329, 565330, 565331, 565332, 565334, 565335, 565336, 565337, 565338, 565339, 565342, 565343, 565344, 565345, 565356, 565359, 565363, 565364, 565365, 565367, 565368, 565371, 565374, 565375, 565376, 565378, 565379, 565383, 565384, 565386, 565388, 565390, 565394, 565396, 565397, 565398, 565401, 565402, 565404, 565406, 565407, 565408, 565409, 565410, 565412, 565415, 565416, 565418, 565421, 565427, 565429, 565433, 565434, 565437, 565440, 565441, 565442, 565444, 565446, 565447, 565448, 565449, 565450, 565452, 565454, 565455, 565457, 565460, 565467, 565469, 565471, 565475, 565476, 565478, 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Model N119 - Serial numbers: 048289, 048292, 048294, 048295, 048296, 048297, 048298, 048299, 048300, 048302, 048303, 048304, 048306, 048307, 048308, 048309, 048310, 048311, 048312, 048313, 048314, 048315, 048318, 048319, 048323, 048325, 048326, 048330, 048332, 048336, 048337, 048338, 048341, 048344, 048408, 048410, 048412, 048413, 048414, 048415, 048416, 048418, 048419, 048420, 048422, 048423, 048425, 048426, 048428, 048430, 048434, 048436, 048440, 048442, 048444, 048447, 048534, 048535, 048537, 048538, 048539, 048540, 048541, 048542, 048543, 048545, 048546, 048547, 048548, 048550, 048551, 048552, 048553, 048554, 048555, 048558, 048560, 048561, 048563, 048564, 048565, 048567, 048570, 048571, 048673, 048676, 048679, 048680, 048681, 048686, 048689, 048691, 048693, 048695, 048698, 048699, 048700, 048701, 048704, 048705, 048707, 048708, 048709, 048710, 048711, 048712, 048713, 048715, 048716, 048720, 048724, 048725, 048726, 048793, 048794, 048812, 048815, 048817, 048818, 048819, 048820, 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Distribution pattern

Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.

device · product 2 of 2

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

Z-0088-2015
Recall number
Z-0088-2015
Initiated
September 17, 2014
Classification
Class II
Status
Terminated
Quantity
31,144 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt

Code information

Model E102 - Serial Numbers: 240307, 240308, 240310, 240312, 240313, 240318, 240319, 240320, 240321, 240324, 240325, 240326, 240327, 240329, 240330, 240332, 240336, 240338, 240340, 240342, 240344, 240345, 240346, 240348, 240349, 240350, 240351, 240354, 240355, 240356, 240358, 240359, 240360, 240363, 240365, 240366, 240367, 240368, 240369, 240371, 240372, 240373, 240374, 240375, 240376, 240378, 240380, 240383, 240384, 240386, 240389, 240391, 240393, 240397, 240398, 240399, 240401, 240403, 240404, 240405, 240406, 240407, 240408, 240410, 240414, 240415, 240416, 240418, 240421, 240422, 240423, 240424, 240426, 240432, 240433, 240434, 240438, 240439, 240441, 240443, 240444, 240448, 240450, 240451, 240452, 240454, 240455, 240456, 240457, 240459, 240460, 240461, 240462, 240466, 240468, 240471, 240472, 240473, 240474, 240475, 240478, 240479, 240480, 240484, 240485, 240488, 240489, 240490, 240491, 240492, 240493, 240496, 240497, 240500, 240501, 240503, 240505, 240508, 240510, 240511, 240512, 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253360, 253362, 253363, 253364, 253365, 253368, 253370, 253371, 253372, 253373, 253374, 253376, 253377, 253378, 253380, 253383, 253384, 253386, 253388, 253389, 253390, 253391, 253395, 253396, 253397, 253398, 253400, 253402, 253404, 253405, 253406, 253407, 253409, 253410, 253411, 253413, 253414, 253415, 253416, 253417, 253420, 253423, 253424, 253425, 253426, 253427, 253428, 253431, 253432, 253433, 253435, 253438, 253440, 253441, 253442, 253445, 253446, 253448, 253449, 253450, 253452, 253453, 253454, 253455, 253456, 253457, 253460, 253461, 253462, 253466, 253469, 253470, 253471, 253472, 253473, 253474, 253475, 253476, 253477, 253478, 253479, 253480, 253481, 253482, 253483, 253484, 253485, 253487, 253488, 253490, 253491, 253492, 253494, 253495, 253496, 253497, 253498, 253499, 253500, 253501, 253503, 253505, 253506, 253508, 253509, 253510, 253511, 253512, 253513, 253514, 253515, 253517, 253518, 253519, 253520, 253521, 253522, 253526, 253528, 253529, 253530, 253531, 253532, 253534, 253535, 253537, 253539, 253542, 253543, 253546, 253547, 253548, 253549, 253550, 253551, 253552, 253553, 253555, 253556, 253560, 253561, 253562, 253563, 253564, 253565, 253568, 253569, 253571, 253573, 253575, 253577, 253579, 253580, 253582, 253583, 253585, 253586, 253587, 253589, 253590, 253591, 253592, 253595, 253597, 253598, 253600, 253601, 253603, 253604, 253605, 253606, 253607, 253608, 253609, 253610, 253611, 253615, 253616, 253618, 253619, 253620, 253621, 253622, 253625, 253626, 253627, 253628, 253629, 253631, 253632, 253635, 253636, 253637, 253638, 253639, 253640, 253641, 253643, 253644, 253645, 253646, 253647, 253648, 253649, 253650, 253652, 253653, 253654, 253656, 253657, 253659, 253661, 253664, 253666, 253667, 253668, 253669, 253672, 253673, 253675, 253677, 253678, 253679, 253680, 253682, 253683, 253684, 253685, 253686, 253687, 253688, 253689, 253690, 253694, 253695, 253696, 253697, 253699, 253700, 253701, 253702, 253704, 253705, 253706, 253708, 253709, 253710, 253711, 253712, 253713, 253714, 253715, 253716, 253717, 253718, 253719, 253720, 253721, 253723, 253724, 253725, 253726, 253727, 253728, 253734, 253735, 253736, 253737, 253738, 253739, 253740, 253742, 253743, 253744, 253745, 253746, 253747, 253748, 253751, 253752, 253753, 253754, 253755, 253756, 253757, 253758, 253759, 253761, 253765, 253766, 253768, 253769, 253772, 253773, 253774, 253775, 253776, 253777, 253778, 253780, 253783, 253784, 253785, 253787, 253788, 253789, 253790, 253791, 253792, 253793, 253794, 253795, 253798, 253800, 253801, 253802, 253803, 253804, 253805, 253806, 253809, 253810, 253812, 253813, 253814, 253815, 253816, 253819, 253820, 253821, 253822, 253824, 253825, 253827, 253828, 253830, 253831, 253832, 253833, 253837, 253840, 253841, 253843, 253846, 253847, 253849, 253850, 253851, 253852, 253855, 253856, 253857, 253859, 253860, 253861, 253863, 253864, 253865, 253866, 253867, 253869, 253870, 253871, 253873, 253874, 253876, 253879, 253880, 253881, 253882, 253884, 253886, 253887, 253889, 253890, 253891, 253892, 253893, 253894, 253895, 253896, 253897, 253898, 253899, 253901, 253903, 253904, 253907, 253908, 253910, 253911, 253912, 253913, 253914, 253915, 253916, 253917, 253919, 253920, 253921, 253922, 253924, 253925, 253926, 253927, 253928, 253930, 253931, 253932, 253933, 253934, 253935, 253936, 253937, 253938, 253939, 253940, 253942, 253943, 253944, 253945, 253946, 253947, 253948, 253949, 253950, 253951, 253952, 253953, 253954, 253955, 253956, 253959, 253960, 253964, 253965, 253967, 253968, 253969, 253971, 253973, 253974, 253975, 253977, 253978, 253979, 253980, 253981, 253982, 253984, 253985, 253987, 253988, 253990, 253991, 253994, 253995, 253996, 253997, 253998, 253999, 254001, 254003, 254004, 254005, 254006, 254007, 254008, 254009, 254010, 254011, 254013, 254014, 254015, 254016, 254017, 254018, 254019, 254020, 254021, 254023, 254025, 254029, 254030, 254032, 254034, 254039, 254043, 254044, 254048, 254049, 254050, 254052, 254053, 254055, 254056, 254057, 254058, 254059, 254060, 254063, 254065, 254066, 254068, 254069, 254070, 254071, 254072, 254075, 254076, 254077, 254078, 254079, 254080, 254081, 254082, 254083, 254084, 254087, 254093, 254095, 254097, 254098, 254100, 254102, 254103, 254105, 254108, 254110, 254111, 254112, 254116, 254118, 254120, 254121, 254122, 254125, 254127, 254128, 254129, 254130, 254132, 254133, 254134, 254136, 254137, 254138, 254139, 254141, 254143, 254144, 254145, 254147, 254150, 254151, 254152, 254154, 254155, 254157, 254158, 254160, 254161, 254164, 254165, 254167, 254169, 254170, 254173, 254174, 254175, 254176, 254177, 254179, 254180, 254182,

Distribution pattern

Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.

Field note

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