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VenaSeal Closure System recallZ-1564-2021 · Medtronic Inc. · initiated Mar 23, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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 [email protected] -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.

Recall details

Recall number
Z-1564-2021
Status
Terminated
Initiated by the company
Mar 23, 2021
Recalling firm
Medtronic Inc.
Quantity
154,152 units
Product code
PJQ
FDA submissions
P140018
Distribution
Distributed nationwide to MA, NY, VT, NH, ME

Product description

VenaSeal Closure System

Code information (models, lots, serial numbers)

Show the full code information (11k characters)

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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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, 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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, 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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.

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under P140018 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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