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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87619

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 23, 2021
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Medtronic Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

VenaSeal Closure System

Z-1564-2021
Recall number
Z-1564-2021
Initiated
March 23, 2021
Classification
Class III
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
154,152 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

Code information

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.

Distribution pattern

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

Field note

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