VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

What Should You Do?

1. Check if you have this product:
   a) U225, Serial Numbers: 707340, 100094, 100142, 100152, 100160, 100184, 100309, 100364, 100807, 100880, 100908, 100913, 700015, 700197, 700469, 700559, 700563, 700576, 700586, 700598, 700613, 700655, 700681, 700682, 700722, 700725, 700782, 700824, 700895, 700942, 700961, 700998, 701017, 701030, 701045, 701094, 701118, 701127, 701212, 701230, 701264, 701336, 701339, 701343, 701407, 701477, 701504, 702448, 702462, 702471, 702654, 702673, 702685, 702809, 703137, 703696, 703697, 703784, 703827, 703875, 703883, 703998, 707324, 707337, 707338, 707347, 707348, 707398, 707430, 707477, 707502, 707503, 707505, 707510, 707511, 707512, 707522, 707524, 707538, 707546, 707566, 707587, 707590, 707597, 100016, 100021, 100023, 100048, 100053, 100059, 100060, 100061, 100064, 100065, 100070, 100072, 100073, 100075, 100077, 100082, 100087, 100088, 100089, 100090, 100093, 100097, 100098, 100100, 100101, 100103, 100105, 100107, 100108, 100109, 100113, 100114, 100115, 100116, 100117, 100118, 100120, 100121, 100122, 100123, 100125, 100126, 100128, 100129, 100130, 100131, 100134, 100135, 100137, 100138, 100140, 100143, 100144, 100145, 100147, 100151, 100153, 100154, 100155, 100156, 100161, 100168, 100169, 100170, 100172, 100173, 100174, 100176, 100181, 100183, 100185, 100186, 100187, 100190, 100191, 100195, 100196, 100197, 100198, 100233, 100238, 100241, 100252, 100266, 100269, 100271, 100273, 100276, 100278, 100282, 100289, 100293, 100296, 100304, 100312, 100313, 100316, 100388, 100395, 100398, 100424, 100428, 100471, 100543, 100545, 100579, 100581, 100595, 100602, 100604, 100610, 100616, 100627, 100712, 100717, 100720, 100734, 100747, 100787, 100800, 100804, 100806, 100810, 100819, 100827, 100828, 100832, 100834, 100835, 100845, 100849, 100850, 100851, 100852, 100853, 100856, 100858, 100865, 100874, 100879, 100887, 100888, 100889, 100890, 100892, 100894, 100895, 100900, 100901, 100902, 100905, 100906, 100907, 100909, 100915, 100916, 100917, 100919, 100921, 100922, 100923, 100924, 100926, 100928, 100929, 100930, 100931, 100932, 100933, 100934, 100935, 700002, 700006, 700013, 700016, 700021, 700024, 700025, 700027, 700035, 700039, 700040, 700043, 700044, 700047, 700048, 700052, 700056, 700060, 700063, 700064, 700067, 700071, 700075, 700077, 700080, 700082, 700083, 700084, 700085, 700088, 700089, 700092, 700094, 700099, 700100, 700102, 700103, 700104, 700105, 700108, 700109, 700110, 700115, 700121, 700125, 700128, 700132, 700134, 700138, 700142, 700145, 700146, 700148, 700151, 700152, 700153, 700155, 700156, 700157, 700159, 700160, 700165, 700170, 700180, 700188, 700189, 700198, 700202, 700203, 700205, 700206, 700209, 700210, 700211, 700214, 700215, 700216, 700217, 700221, 700222, 700225, 700246, 700249, 700268, 700271, 700274, 700278, 700279, 700281, 700285, 700288, 700291, 700292, 700389, 700425, 700427, 700428, 700429, 700430, 700431, 700432, 700433, 700434, 700435, 700446, 700447, 700448, 700449, 700450, 700451, 700452, 700453, 700454, 700455, 700457, 700458, 700459, 700461, 700462, 700463, 700464, 700465, 700467, 700468, 700470, 700471, 700472, 700473, 700474, 700475, 700476, 700477, 700478, 700479, 700480, 700481, 700482, 700483, 700484, 700485, 700486, 700487, 700490, 700491, 700492, 700493, 700494, 700495, 700496, 700497, 700498, 700499, 700500, 700503, 700504, 700506, 700508, 700510, 700511, 700512, 700513, 700514, 700515, 700516, 700522, 700523, 700524, 700525, 700526, 700527, 700528, 700529, 700530, 700531, 700532, 700533, 700534, 700535, 700536, 700537, 700538, 700540, 700541, 700542, 700543, 700544, 700545, 700546, 700547, 700548, 700549, 700550, 700551, 700553, 700555, 700558, 700560, 700561, 700562, 700564, 700566, 700567, 700568, 700570, 700571, 700572, 700573, 700574, 700575, 700577, 700578, 700579, 700580, 700581, 700583, 700584, 700585, 700587, 700588, 700590, 700591, 700592, 700593, 700594, 700595, 700596, 700597, 700599, 700600, 700603, 700604, 700605, 700606, 700607, 700608, 700609, 700610, 700611, 700612, 700614, 700615, 700616, 700617, 700620, 700622, 700623, 700624, 700625, 700626, 700627, 700628, 700629, 700631, 700632, 700633, 700635, 700636, 700637, 700639, 700640, 700641, 700642, 700643, 700644, 700645, 700647, 700648, 700651, 700652, 700653, 700654, 700658, 700659, 700660, 700661, 700663, 700664, 700665, 700666, 700667, 700668, 700670, 700671, 700672, 700673, 700674, 700676, 700677, 700679, 700680, 700683, 700684, 700686, 700687, 700688, 700689, 700690, 700691, 700693, 700694, 700695, 700696, 700698, 700699, 700704, 700705, 700710, 700711, 700712, 700714, 700715, 700716, 700717, 700718, 700719, 700720, 700723, 700724, 700727, 700728, 700729, 700730, 700731, 700732, 700733, 700734, 700736, 700737, 700739, 700740, 700741, 700742, 700743, 700745, 700748, 700749, 700750, 700751, 700752, 700753, 700754, 700755, 700756, 700757, 700758, 700760, 700761, 700764, 700766, 700767, 700768, 700770, 700772, 700773, 700774, 700775, 700776, 700778, 700779, 700780, 700781, 700783, 700785, 700788, 700789, 700790, 700791, 700793, 700794, 700795, 700797, 700799, 700803, 700804, 700807, 700808, 700809, 700810, 700812, 700813, 700815, 700819, 700821, 700822, 700825, 700826, 700827, 700849, 700855, 700857, 700870, 700871, 700872, 700877, 700881, 700885, 700886, 700887, 700888, 700889, 700890, 700891, 700892, 700893, 700894, 700896, 700897, 700899, 700900, 700901, 700902, 700903, 700904, 700905, 700906, 700907, 700908, 700909, 700910, 700913, 700914, 700919, 700920, 700921, 700922, 700923, 700924, 700925, 700926, 700927, 700929, 700933, 700934, 700935, 700936, 700937, 700938, 700939, 700940, 700941, 700945, 700947, 700948, 700949, 700950, 700951, 700953, 700954, 700955, 700957, 700958, 700959, 700962, 700963, 700964, 700966, 700967, 700968, 700969, 700970, 700971, 700972, 700973, 700974, 700975, 700976, 700977, 700979, 700980, 700981, 700983, 700986, 700987, 700988, 700989, 700990, 700991, 700992, 700993, 700994, 700995, 700996, 700997, 701000, 701001, 701004, 701006, 701007, 701009, 701010, 701011, 701013, 701016, 701018, 701019, 701020, 701021, 701022, 701025, 701026, 701027, 701028, 701031, 701035, 701037, 701038, 701039, 701040, 701042, 701043, 701044, 701046, 701047, 701048, 701049, 701051, 701052, 701053, 701054, 701057, 701059, 701061, 701063, 701064, 701066, 701068, 701069, 701070, 701071, 701073, 701074, 701075, 701076, 701078, 701079, 701080, 701083, 701085, 701086, 701087, 701088, 701089, 701090, 701092, 701093, 701095, 701096, 701097, 701098, 701099, 701100, 701101, 701106, 701107, 701108, 701109, 701111, 701112, 701113, 701114, 701116, 701119, 701120, 701121, 701122, 701123, 701124, 701126, 701128, 701129, 701130, 701131, 701132, 701133, 701134, 701135, 701138, 701139, 701140, 701141, 701142, 701143, 701145, 701146, 701148, 701149, 701151, 701152, 701154, 701155, 701158, 701159, 701161, 701162, 701163, 701164, 701166, 701167, 701169, 701170, 701172, 701173, 701174, 701175, 701176, 701177, 701178, 701179, 701180, 701181, 701182, 701183, 701184, 701186, 701187, 701188, 701189, 701190, 701211, 701213, 701214, 701215, 701216, 701217, 701220, 701221, 701225, 701226, 701227, 701228, 701233, 701234, 701235, 701237, 701238, 701239, 701242, 701244, 701245, 701246, 701247, 701248, 701253, 701255, 701257, 701261, 701262, 701263, 701265, 701267, 701268, 701269, 701272, 701274, 701275, 701277, 701286, 701290, 701292, 701293, 701294, 701295, 701298, 701319, 701322, 701324, 701326, 701327, 701328, 701329, 701330, 701331, 701335, 701337, 701340, 701344, 701346, 701347, 701349, 701350, 701353, 701354, 701359, 701360, 701361, 701362, 701363, 701365, 701366, 701367, 701368, 701369, 701370, 701371, 701372, 701373, 701374, 701375, 701376, 701377, 701378, 701379, 701381, 701382, 701383, 701385, 701386, 701387, 701389, 701390, 701395, 701396, 701397, 701398, 701399, 701400, 701401, 701402, 701403, 701404, 701405, 701406, 701408, 701409, 701410, 701412, 701413, 701415, 701417, 701418, 701419, 701420, 701421, 701423, 701425, 701426, 701427, 701428, 701429, 701430, 701431, 701433, 701435, 701437, 701438, 701439, 701440, 701441, 701443, 701444, 701445, 701446, 701448, 701450, 701452, 701453, 701454, 701455, 701456, 701457, 701458, 701459, 701460, 701461, 701462, 701463, 701464, 701465, 701466, 701467, 701468, 701469, 701470, 701471, 701473, 701474, 701475, 701476, 701478, 701479, 701480, 701481, 701482, 701483, 701484, 701487, 701488, 701489, 701490, 701491, 701492, 701493, 701494, 701495, 701496, 701497, 701499, 701500, 701501, 701502, 701503, 701505, 701506, 701507, 701508, 701509, 701510, 701511, 701512, 701513, 701515, 701516, 701518, 701521, 701522, 701523, 701524, 701525, 701526, 701527, 701528, 701530, 701532, 701533, 701534, 701535, 701536, 701537, 701538, 701540, 701541, 701542, 701543, 701544, 701546, 701547, 701548, 701549, 701550, 701551, 701552, 701553, 701554, 701555, 701556, 701557, 701558, 702382, 702397, 702399, 702401, 702415, 702421, 702437, 702442, 702443, 702444, 702454, 702463, 702464, 702465, 702477, 702483, 702501, 702509, 702510, 702514, 702521, 702522, 702523, 702527, 702531, 702536, 702545, 702546, 702547, 702549, 702552, 702555, 702557, 702558, 702561, 702562, 702566, 702570, 702573, 702576, 702579, 702580, 702581, 702582, 702584, 702586, 702590, 702591, 702593, 702595, 702600, 702601, 702603, 702604, 702606, 702610, 702615, 702617, 702618, 702623, 702624, 702626, 702631, 702632, 702636, 702637, 702641, 702643, 702651, 702653, 702655, 702657, 702658, 702660, 702662, 702664, 702666, 702667, 702668, 702669, 702672, 702678, 702682, 702689, 702690, 702698, 702699, 702700, 702701, 702703, 702705, 702706, 702708, 702709, 702711, 702712, 702713, 702714, 702717, 702719, 702721, 702722, 702723, 702725, 702726, 702727, 702728, 702730, 702733, 702735, 702738, 702745, 702756, 702770, 702773, 702779, 702791, 702794, 702796, 702797, 702799, 702831, 702834, 702835, 702837, 702838, 702841, 702843, 702844, 702846, 702847, 702848, 702849, 702850, 702853, 702854, 702857, 702860, 702861, 702862, 702864, 702865, 702867, 702869, 702870, 702871, 702873, 702874, 702875, 702878, 702882, 702883, 702884, 702885, 702886, 702887, 702888, 702890, 702962, 702963, 702965, 702969, 702975, 702979, 702980, 702981, 702983, 702988, 702989, 702994, 702997, 703007, 703035, 703036, 703049, 703053, 703058, 703111, 703115, 703124, 703125, 703263, 703269, 703271, 703273, 703275, 703276, 703563, 703564, 703565, 703566, 703567, 703568, 703569, 703570, 703571, 703615, 703618, 703619, 703620, 703662, 703663, 703664, 703666, 703667, 703668, 703669, 703682, 703685, 703686, 703688, 703694, 703695, 703698, 703699, 703700, 703703, 703704, 703707, 703710, 703719, 703722, 703723, 703729, 703730, 703732, 703739, 703740, 703741, 703747, 703750, 703755, 703765, 703778, 703779, 703790, 703795, 703808, 703810, 703823, 703826, 703830, 703842, 703846, 703847, 703849, 703850, 703858, 703869, 703871, 703872, 703873, 703876, 703879, 703880, 703881, 703882, 703886, 704033, 704034, 704040, 704046, 704049, 704053, 704057, 704062, 704063, 704065, 704066, 704068, 704070, 704079, 704081, 704082, 704083, 704084, 704086, 705127, 705129, 705131, 705133, 705135, 705138, 705139, 707293, 707294, 707298, 707316, 707326, 707327, 707329, 707336, 707339, 707342, 707344, 707346, 707349, 707354, 707356, 707362, 707366, 707378, 707380, 707382, 707386, 707388, 707390, 707392, 707393, 707395, 707396, 707397, 707400, 707401, 707403, 707404, 707405, 707406, 707407, 707408, 707411, 707425, 707426, 707427, 707429, 707431, 707433, 707434, 707436, 707437, 707439, 707440, 707441, 707453, 707463, 707464, 707465, 707466, 707467, 707469, 707474, 707482, 707487, 707489, 707492, 707501, 707506, 707507, 707509, 707515, 707516, 707521, 707523, 707525, 707533, 707534, 707539, 707542, 707543, 707544, 707545, 707548, 707550, 707551, 707553, 707554, 707558, 707559, 707560, 707562, 707567, 707568, 707569, 707570, 707572, 707574, 707576, 707577, 707578, 707579, 707580, 707581, 707583, 707584, 707586, 707589, 707591, 707593, 707594, 707596, 707599, 707600, 707602, 707604, 707605, 707606, 707607, 707608, 707609, 707610, 707613, 707615, 707617, 707619, 707620 b) U226, Serial Numbers: 100044, 100069, 100116, 700077, 700093, 700140, 700163, 700220, 700306, 700323, 700331, 100006, 100009, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100019, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100028, 100029, 100030, 100032, 100034, 100035, 100038, 100039, 100042, 100045, 100046, 100048, 100049, 100050, 100052, 100055, 100058, 100059, 100060, 100061, 100062, 100063, 100066, 100067, 100068, 100070, 100072, 100073, 100074, 100075, 100076, 100077, 100081, 100082, 100085, 100087, 100089, 100090, 100091, 100092, 100094, 100095, 100096, 100098, 100100, 100101, 100102, 100105, 100106, 100107, 100108, 100109, 100111, 100112, 100113, 100117, 100118, 100120, 100123, 100124, 100126, 100127, 100128, 100129, 100132, 100133, 100134, 100135, 100136, 700002, 700003, 700004, 700006, 700007, 700008, 700009, 700010, 700011, 700012, 700013, 700014, 700015, 700018, 700019, 700020, 700021, 700023, 700024, 700025, 700026, 700030, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700042, 700043, 700044, 700045, 700048, 700050, 700051, 700052, 700053, 700054, 700056, 700057, 700058, 700059, 700060, 700061, 700063, 700065, 700066, 700067, 700068, 700071, 700072, 700074, 700075, 700076, 700079, 700081, 700082, 700083, 700084, 700087, 700088, 700089, 700090, 700091, 700092, 700094, 700095, 700096, 700098, 700099, 700101, 700102, 700103, 700106, 700107, 700108, 700109, 700110, 700111, 700113, 700114, 700115, 700116, 700118, 700120, 700121, 700122, 700123, 700124, 700125, 700126, 700132, 700135, 700137, 700139, 700141, 700142, 700143, 700145, 700146, 700147, 700149, 700151, 700153, 700154, 700155, 700156, 700159, 700164, 700167, 700168, 700169, 700170, 700171, 700172, 700183, 700184, 700186, 700187, 700191, 700192, 700193, 700194, 700198, 700199, 700201, 700205, 700207, 700208, 700209, 700210, 700211, 700212, 700213, 700214, 700215, 700216, 700218, 700219, 700222, 700225, 700226, 700227, 700229, 700230, 700231, 700232, 700236, 700237, 700239, 700240, 700241, 700245, 700246, 700247, 700249, 700265, 700309, 700310, 700311, 700312, 700313, 700314, 700316, 700318, 700319, 700321, 700325, 700326, 700327, 700328, 700329 c) U228, Serial Numbers: 702970, 726570, 100020, 100024, 100048, 100074, 100080, 100127, 100129, 100211, 100225, 100230, 100255, 100299, 100496, 101262, 101351, 101386, 101531, 101620, 101741, 101787, 101800, 101883, 101896, 101910, 101982, 102125, 102224, 102298, 700031, 700063, 700124, 700151, 700220, 700234, 700238, 700294, 700403, 700704, 700931, 701037, 701243, 701353, 701496, 701866, 701912, 701959, 702057, 702434, 702597, 702602, 702651, 702839, 703191, 703259, 703318, 703362, 703363, 703962, 703972, 703995, 704020, 704106, 704161, 704579, 704639, 704925, 704982, 705083, 705235, 705390, 705454, 705487, 705575, 705700, 705734, 705739, 705811, 706030, 706035, 706251, 706572, 706585, 706653, 706784, 707069, 709016, 709198, 709260, 709300, 709337, 709982, 710064, 710069, 710090, 710869, 710888, 711240, 711260, 711899, 712093, 712156, 712749, 712858, 712859, 712872, 712885, 712894, 712903, 712908, 713152, 713173, 713246, 713360, 713372, 713398, 713458, 713472, 713513, 713515, 713529, 713537, 713580, 713656, 713734, 713838, 713840, 713886, 713925, 714277, 714284, 714288, 714301, 714353, 714433, 714438, 714448, 714453, 714684, 714696, 714763, 714791, 714794, 714795, 714799, 714815, 715582, 718328, 726154, 726191, 726232, 726331, 726368, 726369, 726381, 726418, 726439, 726448, 726454, 726455, 726457, 726462, 726472, 726482, 726501, 726502, 726519, 726536, 726588, 726663, 726695, 726780, 726797, 726932, 727077, 100004, 100006, 100009, 100010, 100011, 100012, 100015, 100016, 100018, 100019, 100022, 100031, 100032, 100033, 100034, 100035, 100036, 100037, 100039, 100041, 100042, 100045, 100046, 100047, 100049, 100050, 100051, 100053, 100055, 100057, 100059, 100061, 100062, 100064, 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2. Do not eat it: Even if it looks and smells fine, do not consume this product.
3. Throw it away or return it: You can return the product to the store for a full refund.
4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
5. Report problems: Report any issues to the FDA's Safety Reporting Portal.