VenaSeal Closure System recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number SP-101: GTIN 20643169986279, Serial Numbers: 54143, 54145, 54146, 54147, 54148, 54149, 54150, 54151, 54152, 54396, 54397, 54398, 54399, 54417, 54418, 54419, 54420, 54618, 54619, 54620, 54621, 54622, 54771, 54772, 54773, 54774, 54775, 54776, 54794, 54795, 54796, 54924, 54925, 54926, 54927, 54928, 54929, 55027, 55028, 55029, 55030, 55031, 55032, 55068, 55069, 55070, 55071, 55072, 55073, 55113, 55114, 55115, 55116, 55437, 55438, 55439, 55440, 55441, 55442, 55483, 55484, 55485, 55486, 55487, 55488, 55594, 55595, 55596, 55597, 55598, 55599, 55675, 55676, 55677, 55678, 55683, 55684, 55775, 55776, 55777, 55778, 55790, 55791, 55792, 55793, 55794, 55852, 55853, 55854, 55855, 55856, 55948, 55949, 55951, 55952, 55953, 55991, 55992, 55993, 55994, 55995, 56109, 56110, 56111, 56123, 56159, 56160, 56161, 56162, 56163, 56189, 56193, 56195, 56196, 56216, 56218, 56219, 56387, 56388, 56389, 56391, 56464, 56465, 56466, 56467, 56468, 56528, 56529, 56530, 56531, 56532, 56533, 56534, 56661, 56662, 56663, 56664, 56741, 56742, 56829, 56830, 56831, 56832, 56833, 56846, 56847, 56848, 56928, 56929, 56930, 56931, 56932, 56933, 56935, 57063, 57177, 57178, 57179, 57226, 57227, 57268, 57269, 57270, 57271, 57272, 57273, 57439, 57440, 57560, 57561, 57562, 57563, 57564, 57565, 57567, 57884, 57885, 57947, 57948, 58257, 58258, 58363, 58364, 58564, 58566, 58567, 58568, 58897, 58898, 58899, 59249, 59337, 59338, 59339, 59909, 59910, 59911, 60264, 60265, 60682, 60683, 60684, 60685, 60763, 60764, 60765, 60774, 60775, 60776, 60876, 60877, 60880, 60881, 60882, 60883, 60884, 60886, 60887, 60888, 60889, 60890, 60891, 60892, 60893, 60894, 60895, 60896, 60897, 60898, 60899, 60900, 61189, 61190, 61191, 61192, 61193, 61254, 61257, 61262, 61264, 61312, 61313, 61314, 61315, 61598, 61599, 61600, 61605, 61606, 61607, 61612, 61613, 61617, 61925, 61928, 61935, 61936, 61937, 61944, 61946, 61953, 61960, 53106, 53107, 53388, 53449, 54420, 54618, 54929, 55028 Model Number VS-402: GTIN 00613994384089, Serial Numbers: 53830, 54210, 54211, 54421, 55491 GTIN 00643169437937, Serial Numbers: 53841 GTIN 00643169931459, Serial Numbers: 53928 GTIN 20643169986262, Serial Numbers: 53821, 53834, 53835, 53842, 53843, 53845, 53894, 53896, 53900, 53926, 53927, 53929, 53938, 54141, 54212, 54214, 54215, 54216, 54217, 54218, 54220, 54221, 54222, 54287, 54288, 54289, 54291, 54292, 54318, 54320, 54321, 54323, 54325, 54360, 54362, 54363, 54367, 54371, 54372, 54393, 54395, 54422, 54549, 54550, 54552, 54555, 54558, 54559, 54567, 54568, 54695, 54696, 54697, 54698, 54777, 54779, 54780, 54791, 54792, 54793, 54830, 54831, 54834, 55076, 55077, 55110, 55111, 55112, 55227, 55357, 55443, 55444, 55489, 55601, 55602, 55679, 55680, 55686, 55687, 55779, 55782, 55796, 55797, 55860, 55861, 55955, 55959, 55962, 55963, 55971, 56113, 56115, 56116, 56164, 56165, 56166, 56167, 56197, 56198, 56199, 56200, 56201, 56220, 56221, 56222, 56384, 56385, 56386, 56469, 56470, 56471, 56472, 56473, 56535, 56536, 56537, 56641, 56736, 56737, 56739, 56740, 56818, 56819, 56820, 56821, 56822, 56823, 56824, 56825, 56826, 56827, 56840, 56841, 56842, 56843, 56844, 56845, 56937, 56938, 56939, 56940, 56941, 56942, 56943, 56944, 56945, 56946, 56947, 56948, 56949, 56950, 56951, 56952, 56953, 56954, 56955, 57077, 57082, 57180, 57181, 57182, 57183, 57184, 57185, 57186, 57228, 57229, 57230, 57231, 57232, 57233, 57234, 57235, 57236, 57237, 57274, 57275, 57276, 57277, 57278, 57279, 57280, 57281, 57282, 57283, 57284, 57285, 57286, 57287, 57288, 57289, 57290, 57291, 57296, 57297, 57298, 57299, 57568, 57569, 57570, 57571, 57572, 57573, 57574, 57575, 57576, 57577, 57578, 57579, 57580, 57581, 57582, 57583, 57584, 57586, 57587, 57588, 57589, 57590, 57591, 57592, 57593, 57594, 57595, 57596, 57597, 57598, 57599, 57600, 57601, 57602, 57603, 57604, 57605, 57606, 57607, 57608, 57886, 57887, 57888, 57889, 57949, 57950, 57951, 57952, 57953, 57954, 57955, 57962, 57963, 57964, 57965, 57966, 57967, 57968, 57969, 57970, 57971, 57972, 58057, 58058, 58059, 58060, 58061, 58062, 58081, 58082, 58083, 58084, 58085, 58101, 58102, 58103, 58104, 58105, 58107, 58108, 58109, 58110, 58111, 58112, 58113, 58193, 58194, 58195, 58259, 58260, 58261, 58262, 58356, 58357, 58358, 58359, 58360, 58378, 58379, 58380, 58381, 58382, 58383, 58384, 58385, 58386, 58387, 58388, 58389, 58415, 58416, 58417, 58418, 58419, 58420, 58421, 58422, 58423, 58424, 58425, 58426, 58427, 58428, 58429, 58430, 58431, 58432, 58433, 58434, 58435, 58436, 58437, 58438, 58439, 58440, 58441, 58442, 58569, 58570, 58571, 58572, 58573, 58602, 58603, 58604, 58605, 58609, 58610, 58611, 58612, 58613, 58614, 58615, 58616, 58617, 58618, 58619, 58620, 58621, 58622, 58623, 58624, 58625, 58626, 58627, 58628, 58629, 58630, 58631, 58632, 58633, 58634, 58635, 58636, 58637, 58638, 58639, 58640, 58641, 58642, 58643, 58644, 58645, 58646, 58647, 58839, 58901, 58902, 58903, 58904, 58905, 58906, 58907, 58908, 58988, 58989, 58990, 58991, 58992, 58993, 58994, 58995, 58996, 58997, 58998, 58999, 59000, 59001, 59002, 59003, 59004, 59005, 59006, 59007, 59008, 59009, 59010, 59011, 59012, 59013, 59014, 59015, 59016, 59017, 59018, 59019, 59020, 59021, 59022, 59023, 59151, 59234, 59251, 59252, 59253, 59254, 59255, 59256, 59257, 59258, 59259, 59260, 59261, 59262, 59263, 59264, 59265, 59266, 59267, 59268, 59269, 59270, 59271, 59272, 59273, 59274, 59275, 59276, 59277, 59278, 59279, 59280, 59281, 59282, 59283, 59284, 59285, 59286, 59343, 59344, 59345, 59349, 59356, 59357, 59358, 59359, 59360, 59361, 59362, 59363, 59364, 59365, 59366, 59367, 59368, 59584, 59585, 59586, 59690, 59912, 59913, 59914, 59915, 59916, 59954, 59955, 59956, 59957, 59958, 59959, 59960, 59961, 59962, 59963, 59964, 59965, 59966, 59967, 59968, 59969, 59970, 59971, 59972, 59973, 59974, 60124, 60266, 60267, 60268, 60269, 60270, 60271, 60272, 60273, 60274, 60275, 60276, 60277, 60278, 60279, 60280, 60281, 60282, 60283, 60687, 60688, 60689, 60690, 60691, 60692, 60693, 60694, 60695, 60766, 60767, 60768, 60777, 60778, 60779, 60780, 60781, 60782, 60783, 60784, 60785, 60786, 60787, 60788, 60793, 60794, 60795, 60796, 60797, 60798, 60799, 60800, 60801, 60812, 60813, 60814, 60815, 60816, 60818, 60819, 60820, 60821, 60822, 60823, 60824, 60825, 60826, 60828, 60829, 60830, 60831, 60832, 60833, 60834, 60878, 60879, 60901, 60902, 60903, 60904, 60905, 60906, 60907, 60908, 60909, 61187, 61188, 61246, 61247, 61248, 61249, 61250, 61251, 61252, 61253, 61258, 61259, 61260, 61261, 61265, 61266, 61267, 61268, 61269, 61270, 61271, 61272, 61273, 61274, 61275, 49967, 50226, 50229, 50431, 50547, 50651, 50816, 50832, 50833, 50972, 51017, 51076, 51077, 51178, 51195, 51307, 51310, 51461, 51509, 51590, 51657, 51659, 51660, 51752, 51755, 51757, 51768, 51794, 51795, 51856, 51859, 51872, 51908, 51909, 51910, 51958, 51961, 51982, 52028, 52029, 52128, 52129, 52130, 52138, 52139, 52217, 52222, 52224, 52225, 52226, 52274, 52275, 52293, 52294, 52297, 52372, 52373, 52412, 52413, 52414, 52415, 52416, 52417, 52420, 52426, 52427, 52429, 52438, 52441, 52445, 52447, 52448, 52449, 52454, 52483, 52485, 52487, 52488, 52489, 52490, 52491, 52504, 52505, 52506, 52599, 52600, 52601, 52602, 52639, 52640, 52641, 52642, 52646, 52647, 52648, 52649, 52706, 52707, 52708, 52718, 52719, 52720, 52721, 52722, 52723, 52728, 52729, 52737, 52738, 52739, 52740, 52741, 52790, 52791, 52792, 52793, 52794, 52795, 52796, 52797, 52801, 52802, 52803, 52804, 52805, 52806, 52815, 52816, 52817, 52818, 52819, 52820, 52821, 52823, 52829, 52832, 52833, 52834, 52835, 52836, 52837, 52838, 52839, 52895, 52896, 52897, 52898, 52899, 52900, 52901, 52902, 52903, 52904, 52905, 52910, 52911, 52912, 52913, 52914, 52915, 52916, 52917, 52918, 52938, 52939, 52940, 52941, 52942, 52943, 52944, 52945, 53025, 53026, 53042, 53043, 53044, 53051, 53052, 53053, 53054, 53055, 53056, 53057, 53058, 53060, 53061, 53062, 53063, 53064, 53098, 53099, 53100, 53101, 53170, 53171, 53172, 53173, 53174, 53175, 53176, 53186, 53187, 53188, 53189, 53190, 53197, 53198, 53199, 53200, 53201, 53202, 53212, 53213, 53214, 53215, 53216, 53217, 53254, 53255, 53256, 53257, 53258, 53259, 53260, 53261, 53262, 53263, 53264, 53265, 53266, 53267, 53268, 53317, 53318, 53319, 53320, 53321, 53322, 53323, 53324, 53325, 53326, 53327, 53328, 53339, 53459, 53460, 53461, 53463, 53464, 53465, 53466, 53467, 53468, 53539, 53540, 53541, 53542, 53543, 53562, 53563, 53565, 53566, 53567, 53584, 53585, 53586, 53587, 53588, 53637, 53638, 53639, 53640, 53652, 53653, 53654, 53655, 53656, 53703, 53712, 53713, 53714, 53715, 53716, 53718, 53719, 53720, 53721, 53722, 53814, 53815, 53816, 53817, 53818, 53819, 53820, 53821, 53830, 53831, 53832, 53833, 53834, 53835, 53841, 53842, 53843, 53844, 53845, 53846, 53890, 53895, 53896, 53897, 53898, 53899, 53900, 53901, 53925, 53926, 53927, 53928, 53929, 53931, 53936, 53937, 53938, 53939, 53940, 53941, 54052, 54053, 54054, 54140, 54141, 54209, 54210, 54211, 54212, 54214, 54215, 54216, 54217, 54218, 54219, 54220, 54221, 54287, 54288, 54289, 54290, 54291, 54318, 54320, 54321, 54322, 54323, 54324, 54325, 54326, 54327, 54359, 54360, 54361, 54362, 54363, 54364, 54365, 54366, 54367, 54368, 54369, 54370, 54371, 54372, 54373, 54392, 54393, 54394, 54395, 54421, 54422, 54423, 54424, 54451, 54452, 54453, 54454, 54455, 54456, 54457, 54549, 54550, 54551, 54552, 54553, 54554, 54555, 54556, 54557, 54558, 54559, 54567, 54568, 54695, 54696, 54697, 54698, 54777, 54778, 54779, 54780, 54781, 54782, 54783, 54790, 54791, 54792, 54793, 54830, 54831, 54832, 54833, 54834, 55074, 55075, 55076, 55077, 55107, 55108, 55109, 55110, 55111, 55112, 55224, 55225, 55226, 55227, 55228, 55229, 55230, 55231, 55353, 55354, 55355, 55356, 55357, 55358, 55359, 55360, 55361, 55362, 55364, 55365, 55443, 55444, 55445, 55489, 55490, 55491, 55600, 55601, 55602, 55679, 55680, 55681, 55682, 55685, 55686, 55687, 55779, 55780, 55781, 55782, 55795, 55796, 55797, 55858, 55859, 55860, 55861, 55862, 55955, 55959, 55962, 55963, 55970, 56114, 56115, 56164, 56165, 56166, 56167, 56197, 56198, 56199, 56200, 56202, 56384, 56469, 56470, 56473 Model Number VS-404: GTIN 00643169437975, Serial Numbers: 61677 GTIN 00673978070469, Serial Numbers: 62015 GTIN 00673978070872, Serial Numbers: 62006 GTIN 00763000240776, Serial Numbers: 61475, 61673, 61674, 61678, 61696, 61933, 61934, 61938, 61939, 61940, 61941, 61943, 61947, 62013, 62022 GTIN 00763000279769, Serial Numbers: 61675 Please note that VS-403 is not approved in the U.S. and has not been distributed outside of the United States; the scope of this corrective action will include this product as it is launched in OUS regions beginning Summer 2021.

Product

VenaSeal Closure System

Recalling firm

Medtronic Inc.

Quantity

154,152 units

Distribution

Distributed nationwide to MA, NY, VT, NH, ME

Recall date

May 19, 2021

Classification

Class III

Status

Terminated

Agency

FDA (device)