VenaSeal Closure System
- Company
- Medtronic Inc.
- Recall Initiated
- March 23, 2021
- Recall Number
- Z-1564-2021
- Quantity
- 154,152 units
- Firm Location
- Plymouth, MN
Reason for Recall
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
Distribution
Distributed nationwide to MA, NY, VT, NH, ME
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
A Recall notification letter titled, "URGENT: MEDICAL DEVICE CORRECTION" was sent to consignees on 03/23/2021 via UPS 2-day delivery. The consignee is requested to: -Review the VenaSeal Gun Assist Process as provided in Appendix A. -Please share this information with any other healthcare professionals in their facility who use the VenaSeal Closure System. Also share this information with any other organization where these devices may have been transferred. -Maintain a copy of this letter for the consignee's reference. -Please complete the enclosed Customer Confirmation Form and return via email toRS.CFQFCA@medtronic.com -Please notify Medtronic of any adverse events or quality problems associated with use of this product. -Complete and submit the report Online: www.fda.gov/medwatch/report.htm -Regular Mail or Fax: Download form www.fda.gov/MedWatch/getformstm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178 In other geographies, communication of the Medical Device Correction letter began on 23-Mar-2021, via regionally approved methods. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification.