Boston Scientific CRM Corp: Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.

Recall number

Z-1554-2010

Recalling firm

Boston Scientific CRM Corp

Product

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.

Status

Terminated

Initiated

2010-03-15

Posted

2010-05-08

Terminated

2012-04-05

Reason

Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after determining that some manufacturing process changes were not submitted for approval to the US Food & Drug Administration.

Root cause

PMA

Action

BSC issues press release dated 15 March 2010. FDA press release posted 18 March 2010. On 15 March 2010, BSC Sales Representatives begin removal of devices from health care facilities stock. Starting 22 March 2010 BSC sent a physician letter dated 22 March 2010 to implanting and following physicians via FedEx. The Urgent Medical Device Recall letter described the issue of why devices were being removed from hospital shelves. The letter did NOT recommend any changes to normal follow-up procedures for patients implanted with an ICD or CRT-D device. The letter included ALL potential US models. To be complete and mitigate the possibility of retrieval errors, the ICD and CRT-D US models that may be on customer's shelves were included in the letter. The devices subject to retrieval, however, were those non-implanted devices with domestic customers. For questions, please contact the local representative (1-800-227-3422) for pick up and return or contact Boston Scientific Technical Services at 1.800.CARDIAC (227.3422).

Quantity

799

Distribution

nationwide within US only (OUS distribution not affected).

Lot, serial or model codes

Model N118, serial numbers: 564225, 568144, 569074, 569104, 569150, 569690, 569737, 569866, 569996, 569998, 570003, 578083, 578441, 578668, 578673, 578746, 578748, 578758, 578761, 578800, 578810, 578822, 578834, 578845, 578855, 578893, 578918, 578921, 578924, 578944, 578945, 578953, 578956, 578975, 578978, 578984, 579024, 579031, 579043, 579055, 579070, 579085, 579100, 579105, 579123, 579200, 579228, 579448, 579502, 579519, 579587, 579595, 579605, 579624, 579707, 579773, 579776, 579780, 579789, 579793, 579794, 579795, 579798, 579800, 579803, 579809, 579810, 579811, 579813, 579817, 579818, 579819, 579844, 579857, 579862, 579866, 579868, 579879, 579880, 579894, 579897, 579900, 579906, 579914, 579916, 579920, 579927, 580007, 580315, 580337, 580379, 580391, 581909, 581922, 581960, 581966, 581974, 581999, 582012, 582025, 582028, 582052, 582068, 582069, 582094, 582099, 582101, 582105, 582131, 582137, 582152, 582159, 582200, 582225, 582278, 582279, 582280, 582313, 582317, 582329, 582330, 582347, 582365, 582402, 582405, 582407, 582412, 582447, 582457, 582471, 582495, 582508, 582551, 582564, 582589, 582590, 582727, 582787, 582820, 582823, 582827, 582830, 582863, 582882, 582887, 582918, 582945, 582958, 582961, 582966, 582993, 582997, 582998, 583006, 583020, 583021, 583034, 583038, 583039, 583052, 583058, 583060, 583076, 583077, 583079, 583093, 583094, 583117, 583140, 583141, 583148, 583185, 583217, 583233, 583245, 583250, 583251, 583259, 583262.  Model N119, serial numbers: 058537, 058899, 058989, 169937, 171259, 172468, 173571, 174731, 175333, 180258, 181817, 181944, 182893, 184121, 185550, 186643, 186723, 188751, 189460, 190554, 190724, 192369, 193725, 194834, 196314, 196319, 196944, 197243, 197340, 197530, 198559, 198563, 198646, 199247, 199557, 200322, 200333, 201344, 201447, 202619, 203198, 206554, 206562, 207971, 208920, 208977, 209055, 209225, 947264, 947354, 948235, 948250, 948409, 948531, 948542, 948939, 949460, 949510, 949529, 949824, 949894, 953082, 953134, 953436, 953524, 953544, 953551, 954004, 954017, 954157, 954178, 954305, 954312, 954317, 954339, 954363, 954364, 954403, 954422, 954672, 954678, 954686, 954700, 954944, 954946, 954967, 955012, 955013, 955026, 955627, 955632, 955635, 955670, 955677, 955682, 955683, 955707, 955709, 955754, 955766, 955952, 955961, 955962, 955987, 955990, 955992, 956007, 956035, 956041, 956047, 956053, 956347, 956358, 956426, 956477, 956765, 957266, 957301, 957304, 957316, 957369, 957422, 957425, 957437, 957474, 957476, 957487, 957521, 957608, 957878, 957969, 958152, 958298, 958529, 958535, 958555, 958563, 958583, 958616, 958683, 958775, 958837, 958838, 958898, 958901, 958902, 959046, 959070, 959078, 959098, 959101, 959169, 959183, 959188, 959200, 959225, 959279, 959327, 959341, 959363, 959367, 959391, 959395, 959398, 959401, 959827, 960273, 960275, 960278, 960282, 960290, 960291, 960454, 960484, 960489, 960495, 960498, 960500, 960503, 960527, 960545, 960552, 960563, 960571, 960575, 960582, 960584, 960586, 960687, 960701, 960710, 960712, 960717, 960736, 960747, 960882, 960903, 960906, 960932, 960972, 960975, 960976, 960979, 961036, 961041, 961046, 961047, 961049, 961091, 961092, 961093, 961101, 961102, 961108, 961163, 961175, 961182, 961184, 961189, 961190, 961202, 961204, 961257, 961261, 961266, 961273, 961274, 961282, 961286, 961291, 961387, 961389, 961398, 961399, 961407, 961412, 961416, 961427, 961445, 961451, 961457, 961462, 961467, 961470, 961474, 961483, 961486, 961689, 961690, 961738, 961742, 961746, 961751, 961752, 961798, 961800, 961855, 961860, 961861, 961869, 961872, 961886, 961897, 961901, 961907, 961917, 962032, 962359, 962381, 962428, 962465, 962797, 963255, 963268, 963280, 963290, 963828, 964028, 964037, 964043, 964047, 964100, 964117, 964128, 964160, 964252, 964265, 964271, 964659, 964733, 965297, 966005, 966140, 968984, 968988, 968996, 968998, 969006, 969007, 969044, 969049, 969062, 969109, 969117, 969174, 970703, 970710, 970747, 970755, 970766, 970799, 970813, 970816, 970822, 970827, 970849, 970855, 970860, 970873, 970876, 970885, 970888, 970891, 970892, 970898, 970971, 971013, 971016, 971041, 971047, 971054, 971443, 971469, 971491, 971494, 972130, 972146, 972160, 972166, 972418, 972423, 972516, 972529, 972536, 972539, 972543, 972597, 972600, 972601, 972602, 972607, 972614, 972642, 972882, 972883, 972884, 972916, 972920, 972922, 972925, 972927, 972932, 972947, 972963, 973325, 973333, 973340, 973345, 973348, 973452, 973454, 973462, 973467, 973479, 973496, 973513, 973590, 973591, 973709, 973728, 973736, 973738, 973749, 973750, 974239, 974245, 974252, 974256, 974260, 974269, 974285, 974288, 974290, 974297, 974307, 974379, 974398, 974423, 974432, 974527, 974560, 974564, 974584, 974590, 974598, 974636, 975007, 975021, 975039, 975051, 975059, 975061, 975160, 975164, 975200, 975476, 975490, 975492, 975599, 975607, 975683, 975730, 975813, 975830, 975836, 975901, 976453, 976454, 976455, 976457, 976462, 976492, 976493, 976499, 976503, 976507, 976510, 976515, 976524, 976540, 976542, 976580, 976582, 976843, 976853, 976863, 976869, 976871, 976904, 976924, 976926, 976932, 977014, 977030, 977034, 977050, 977122, 977126, 977132, 977150, 977152, 977157, 977163, 977176, 977178, 977179, 977190, 977191, 977192, 977725, 977727, 977732, 977746, 977752, 977754, 977771, 977778, 977782, 977784, 977805, 977809, 977824, 977826, 977827, 977850, 977907, 977908, 977932, 977933, 977936, 977939, 977940, 977943, 977944, 977945, 977946, 977954, 977958, 978020, 978028, 978396, 978402, 978410, 978419, 978420, 978428, 978434, 978437, 978445, 978446, 978448, 978454, 978458, 978462, 978465, 978471, 978472, 978474, 978486, 978492, 978506, 978553, 978570, 978578, 978580, 978586, 978600, 978601, 978616, 978623, 978628, 978689, 978694, 978695, 978696, 978708, 978712, 978716, 978718, 978964, 978966, 978967, 978970, 978977, 978978, 979023, 979024, 979025, 979029, 979034, 979035, 979047, 979048, 979050, 979101, 979107, 979401, 979409, 979418, 979524, 979529, 979533, 979603, 979611, 979619, 979697, 979709, 979739, 979744, 979748, 979749, 979751, 979756, 979757, 979766, 979771, 979775, 979777, 979778, 979780, 979804, 979805, 979807, 979810, 979815, 979839, 979857, 979865, 979868, 979873, 979881, 980113, 980115, 980116, 980117, 980123, 980126, 980129, 980559, 980577, 980675, 980702, 980868, 980872, 981344, 981423, 981424, 981491, 981837, 981840, 981906, 981972, 981983, 981988, 982610, 982863, 983662, 983999, 984030, 984044.

510(k) numbers

not on file

PMA numbers

["P010012S165"]

Product code

LWP

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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