Device Recall INSIGNIA Entra and NEXUS Entra

model 484, serial numbers: 119165 119166 119171, 119175 thru 119204, 119209 thru 119243, 119245 thru 119365, 119368 thru 119373, 119376, 119377, 119378, 119379, 119382, 119383, 119384 thru 119392, 119413 thru 119428, 119430 thru 119514, 119520, 119543, 119544, 119569, 119570, 119571, 119572, 119592, 119596 thru 119626, 119628 thru 119668, 119670 thru 119750, 119752,  thru 119816, 119818 thru 119870, 119872 thru 119951, 119953 thru 119992, 120014, 120017, 120018, 120019, 120020, 120028, 120029, 120032.   model 485, serial numbers: 100172 thru 100179 and 100181 thru 100191.   model 985, serial numbers: 103071 thru 103086.  model 986, serial numbers: 111738, 111739, 111740, 111742,  111743, 111744, 111752, 111755, 111761 thru 111772, 111775 thru 111781, 111783 thru 111860, 111866, 111870, 111873, 111874 thru 111890, 111892, 111897, 111901 thru 111911, 111913 thru 112011, 120213 thru 112048, 112050 thru 112062, 112095, 112097 thru 112100, 112103, 112105 thru 112172, 112175 thru 112263, 112266, 112268 thru 112274, 112277 thru 112304, 112306, 112308 thru 112345, 112347 thru 112376, 112378 thru 112390, 112392 thru 112457, 112459 thru 112519, 112521 thru 112593, 112595 thru 112642, 112645, 112646, 112647, 112650, 112653, 112656, 112657, 112663, 112706.   model 1195, serial numbers: 104431 thru 104434, 104436,  104437, 104439, 104440, 104442, 104444, 10445 thru 104477, 104481, 104483 thru 104489, 104491, 104492, 104494 thru 104501, 104509, 104522 thru 104524, 104526,  104529, 104531, 104532, 104534, 104535, 104536, 104537, 104542 thru 104557, 104559 thru 104609, 104611 thru 104677, 104679 thru104681, 104687, 104688, 104689,  104696, 104706, 104707, 104708, 104716, 104717, 104719,  104723, 104724, 104727, 104728, 104729, 104758, 104759, 104760, 104761, 104762, 104766, 104767, 104768, 104771,  104773, 104794 thru 104897, 104899 thru 104918, 104920 thru 104923, 104925 thru 104973, 104976, 104985, 104986.   model 1198, serial numbers: 128758, 128759, 128763,  128764 thru128767, 128770, 128771, 128774 thru128776,  128789 thru 128791, 128793 thru 128795, 128797, 128800,  128802 thru 128806, 128813 thru 128819, 128821 thru 128824, 128833 thru 128835, 128838, 128839, 128842,  128843, 128848 thru 128931, 128933 thru 128939, 128941, 128945 thru 128949, 128951 thru 128955, 128957, 128959, 128965 thru 128970, 128973, 128974, 128977 thru 128986, 128988 thru 128990 128992, 128993, 128995 thru 129010, 129013 thru 129023, 129025 thru 129046, 129048 thru 129070, 129072 thru 129075, 129077 thru 129082, 129085 thru 129090, 129092, 129093, 129096 thru 129119, 129121 thru 129152, 129157 thru 129310, 129312 thru 129349, 129351 thru 129472, 129477 thru 129484, 129490, 129497 thru 129509, 129512 thru 129520, 129522, 129523, 129525 thru 129532, 129537 thru 129544, 129548 thru 129568, 129570 thru 129572, 129575 thru 129580, 129585 thru 129592, 129606, 129607, 129610, 129611, 129616, 129619,  129624, 129625, 129628, 129632, 129633, 129635 thru 129651, 129653 thru 129676, 129853 thru 130048, 130081 thru 130151, 130153 thru 130205, 130207 thru 130223, 130225 thru 130280, 130282 thru 130322, 130324 thru 130373, 130377, 130378, 130380, 130388 thru 130391,  130400 thru 130403, 130412 thru 130415, 130424, 130426,  130427, 130434, 130450, 130461, 130462, 130463, 130483,  130485, 13048, 130487, 130488, 130521, 130552, 130553,  130561, 130565, 130569, 130570, 130571, 130573, 130574, 130575, 130576, 130590, 130597, 130599, 130604, 130675,  130761, 130762, 130764, 130797, 130798, 130799, 130825,  130826, 130827, 130841, 130842, 130843, 130844, 130845,  130846, 130848, 130853, 130854, 130857, 130858, 130859,  130860, 130865, 130867, 130868, 130869, 130870, 130871,  130874, 130882, 130891 thru 130896, 1300905 thru 130917, 130920, 130921, 130923, 130924, 130930 thru 130984, 130991, 130992, 130994, 130995, 130998 thru 131000, 131002, 131005 thru 131010, 131012 thru 131017, 131019 thru 131021, 131023 thru 131030, 131034 thru 131048, 131050 thru 131093, 131098, 131099, 131101 thru 131142, 131144 thru 131187, 131194 thru 131209, 131211 thru 131228, 131231 thru 131235, 131237, 131238, 131240 thru 131300, 131303 thru 131462, 131464 thru 131533, 131535, 131536, 131538 thru 131634, 131636 thru 131769, 131794 thru 131812, 131814 thru 131928, 131930 thru 131964, 131966 thru 132161, 132163 thru 132263, 132265 thru 132279, 132281 thru 132285, 132289 thru 132295, 132298 thru 132301, 132303, 132305 thru 132362, 132364 thru 132368, 132370 thru 132377, 132379, 132381 thru 132385, 132387 thru 132397, 132399, 132400, 132402, 132403 thru 132406, 132408 thru 132415, 132417 thru 132476, 132478, 132480 thru 132482, 132484, 132485, 132490 thru 132492, 132494 thru 132498, 132501 thru 132507, 132510, 132511,  132512, 132513, 132516, 132517, 132518, 132520, 132521,  132523, 132524, 132526, 132527, 132529, 132590, 132601,  132602, 132604, 132643.  model 1294, serial numbers: 949571 thru 949899, 949901 thru 949929, 949935 thru 949937, 949940, 949943 thru 949954, 949961 thru 949967, 949969, 949971 thru 949973, 949975 thru 949982, 949987 thru 949992, 950003, 950007, 950009 thru 950042, 950047, 950048, 950050 thru 950062, 950064 thru 950066, 950071, 950075 thru 950079, 950082 thru 950100, 950102 thru 950104, 950106 thru 950110, 950112 thru 950128, 950130 thru 950170, 950172 thru 950194, 950197 thru 950440, 950442 thru 950489, 950491 thru 950608, 950629 thru 950650, 950656, 980711, 950715,  950728, 950729, 950755, 950756, 950759, 950761, 950762, 950763, 950764, 950765, 950766, 950767, 950768, 950788,  950789, 950791, 950792, 950800, 950805, 950865, 950867,  950868, 950870, 950872 thru 950877, 950879, 950880,  950883 thru 950889, 950892, 950893, 950895 thru  950903, 950906 thru 950920, 950922 thru 950932, 950934, 950935, 950937 thru 950965, 950969, 950971, 950973 thru 950998, 951001 thru 951003, 951006, 951009 thru 951037, 951040 thru951058, 951060 thru 951070, 951072, 951073, 951075, 951080 thru 951105, 951107 thru 951116, 951118 thru 951122, 951125 thru 951234, 951236 thru 951273, 951275 thru 951318, 951320 thru 951331, 951337 thru 951394, 951236 thru 951273, 951275 thru 951318, 951320 thru 951331, 951337 thru 951394, 951396 thru 951416, 951419 thru 951608, 951610 thru 951637, 651639 thru 951648, 9951650 thru 951870, 951872 thru 951900, 951902 thru 952000, 952002 thru 952019, 952021, 952023, 952024, 952026 thru 952031, 952033 thru 952036, 952038 thru 952041, 952077, 952089, 952090, 952113, 952116, 952119, 952121, 952126, 952131, 952132, 952136, 952264, 952295.  model 1295, serial numbers: 104110 thru104134, 104136, 104141, 104145, 104146, 104148 thru 104150, 104154, 104155, 104157 thru 104165, 104170, 104174 thru 104182, 104184 thru 104232, 104234, 104240 thru 104243, 104245 thru 104247, 104250 thru104252, 104254 thru 104286, 104288 thru 104306, 104309, 104310, 104312, 104313, 104315 thru 104343, 104346, 104347, 104349 thru104357, 104361, 104364 thru 104368, 104370 thru 104383, 104385 thru 104396, 104398, 104400 thru 104404, 104406 thru 104524, 104527, 104531, 104532, 104533, 104540, 104557, 104558, 104566, 104567, 104587 thru 104592, 104594 thru 104667, 104669 thru 104672, 104674 thru 104690.  model 1296, serial numbers: 130965 thru 130967, 130970, 130977 thru 130979, 130981, 130982, 130984, 130987 thru 130993, 130995, 130996, 131001 thru 131003, 131005, 131021 thru 131085, 131087 thru 131111, 131113 thru 131129, 131131 thru 131151, 131153thru 131216, 131220, 131223, 131226 thru 131231, 131234, 131241 thru 131247, 131250, 131254, 131258, 131285, 131286, 131289, 131292 thru 131312, 131316 thru 131340, 131355 thru 131364, 131369 thru 131390, 131393 thru 131404, 131409 thru 131416, 131481 thru 131427, 131429 thru 131480, 131496, 131499, 131506 thru 131509, 131511 thru 131514, 131517, 131528, 131531, 131661 thru 131773, 131775 thru 131918, 131920 thru 131940, 131942 thru 131990, 131992 thru 131102, 132115, 132116, 132118, 132119, 132122 thru 132125, 132129, 132131, 132132, 132134 thru 132136, 132138, 132147, 132148, 132150 thru 132157, 132167 thru 132169, 132171 thru 132174, 132176 thru 132179, 132189, 132190, 132238 thru 132242, 132250, 132261, 132263, 132264, 132271, 132296, 132299, 132300, 132310, 132431, 132434 thru 132438, 132441 thru 132443, 132448, 132451 thru 132458, 132462, 132483 thru 132487, 132495, 132496, 132499 thru 132501, 132508 thru 132510, 132518 thru 132523, 132525, 132527, 132528, 132531 thru 132618, 132620 thru 132644, 132646 thru 132649, 132651, 132652, 132654 thru 132671, 132673 thru 132681, 132685 thru 132765, 132767, 132768, 132771 thru 132784, 132786 thru 132788, 132790 thru 132839, 132841, 132842, 132844 thru 132854, 132856 thru 132880, 132882 thru 132988, 132992 thru 133005, 133007 thru 133084, 133086 thru 133202, 133204, 133205, 133207 thru 133234, 133236 thru 133274, 133276, 133278 thru 133328, 133330 thru 133688, 133690 thru 133707, 133709 thru 133784, 133786 thru 133816, 133818 thru 133919, 133921 thru 133976, 133978 thru 134024, 134026 thru 134049, 134051 thru 134090, 134097 thru 134102, 134112, 134113, 134115, 134116, 134117, 134120 thru 134129, 134131 thru 134135, 134147 thru 134149, 134153 thru 134159, 134161, 134162, 134164, 134165, 134167 thru 134179, 134181, 134182, 134187, 134402, 134404, 134405, 134410 . model 1326, serial numbers: 100507, 100508, 100510 thru 100534, 100536 thru 100566. model 1426, serial numbers: 100534 thru 100553 model 1398, serial numbers: 100837 thru 100856, 100858 thru 100864, 100866, 100867, 100869, 100870, 100879 thru 100898, 100914, 100916 thru 100983, 100986 model 1466, serial numbers: 100354 thru 100357, 100359, 100362 thru 100378, 100381, 100384, 100385, 100386, 100389, 100393, 100395, 100396, 100398 thru 100411, 100413, 100418 thru 100541, 100543 thru 100547, 100549 thru 100638, 100640, 100643 thru 100645. model 1494, serial numbers: 100218 thru 100262, 100264 thru 100266, 100268 thru 100293, 100296.

Cardiovascular Devices

3

Yes

Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Micronesia, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela

Guidant INSIGNIA I Entra-- family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). --Intermedics NEXUS Entra--family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1466, 1494). --The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. -----The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Quantities Distributed by model are as follows: INSIGNIA ENTRA SSI model 484=704 devices, model 485 = 10; DDD model 985 = 13, model 986 = 779; SR model 1195 = 393, model 1198 = 2,693; DR model 1294 = 2,029, model 1295 = 439, model 1296 = 2,361; NEXUS ENTRA SSI model 1326 = 55; DDD model 1426 = 7; SR model 1395 = 45, 1398 = 117; DR model 1466 = 264, model 1494 = 46, model 1495 = 17.