VenaSeal Closure System
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, 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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, 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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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Inc.
- Reason for Recall:
- Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
VenaSeal Closure System
Product Codes/Lot Numbers:
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, 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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, 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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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1564-2021
Related Recalls
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.