Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
This recall is currently active, issued October 9, 2024. It was issued by Inspire Medical Systems Inc..
- Company
- Inspire Medical Systems Inc.
- Recall Initiated
- July 31, 2024
- Posted
- October 9, 2024
- Recall Number
- Z-0041-2025
- Quantity
- 457 units
- Firm Location
- Golden Valley, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Distribution
Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.
Lot / Code Info
Model 4063. UDI-DI: 10855728005793. Part Number: 900-013-001. Serial Numbers: T52648, T52644, T52642, T52640, T52635, T52630, T52634, T52615, T52611, T52654, T52655, T52607, T52604, T52609, T52603, T52595, T52597, T52616, T52594, T52591, T52590, T52592, T52612, T52588, T52625, T52579, T52566, T52561, T52522, T52523, T48445, T48424, T48403, T48388, T48357, T48352, T48345, T48340, T48331, T48332, T48333, T48288, T11952, T11955, T48282, T48265, T48255, T48253, T48254, T48217, T48188, T48184, T48167, T48189, T48213, T48166, T48161, T48153, T48149, T48144, T47959, T47947, T47940, T48435, T47936, T47820, T47818, T47805, T47785, T47772, T47770, T47761, T47748, T47747, T47733, T47731, T47708, T47709, T47683, T47660, T47767, T47768, T47630, T47617, T47615, T47614, T47490, T47473, T47924, T47459, T47447, T47417, T48170, T47400, T47389, T45700, T47824, T47368, T47364, T47354, T43971, T48314, T47349, T47356, T47415, T47342, T47303, T47211, T47440, T46791, T47196, T47186, T47187, T47198, T47200, T43079, T47149, T47144, T47167, T47138, T48262, T47132, T47116, T47206, T47067, T46826, T47674, T46821, T46820, T46802, T46799, T46798, T46797, T46760, T46742, T46714, T46700, T46596, T46592, T46588, T46562, T46563, T46559, T46526, T46353, T46336, T46313, T52538, T46300, T52515, T52520, T46295, T45740, T45736, T45720, T45701, T45697, T45679, T45420, T45405, T45375, T45372, T45366, T45358, T45347, T45333, T45132, T44982, T44965, T44933, T44931, T44911, T44754, T44698, T43947, T43938, T43918, T43910, T43902, T43898, T43881, T43873, T43799, T43795, T43784, T43763, T43754, T43741, T43716, T43732, T43704, T43516, T43506, T43361, T43362, T43363, T43328, T43338, T43326, T43322, T43323, T43101, T43115, T43117, T43299, T43291, T43264, T43249, T43244, T43238, T43236, T43135, T43108, T43096, T30899, T30916, T47710, T47711, T47712, T43093, T43064, T42831, T42814, T42805, T43273, T42794, T42789, T42781, T42760, T42574, T42592, T42593, T42568, T42323, T42122, T47758, T47786, T41973, T52549, T41953, T41954, T41944, T41926, T41927, T41921, T41577, T46721, T46723, T48356, T48360, T10211, T10287, T41920, T41918, T41824, T41780, T43761, T41759, T48215, T41724, T41697, T29941, T29951, T44953, T42298, T42299, T41671, T41649, T47826, T41547, T47312, T41434, T41425, T41670, T41707, T41420, T44681, T47136, T41296, T43889, T43969, T41259, T41277, T41249, T41244, T41195, T42319, T41063, T40951, T41040, T40983, T40959, T40957, T40917, T40849, T40846, T40762, T40763, T40725, T40573, T40708, T40560, T29971, T40110, T40100, T40095, T40043, T38150, T40014, T39976, T39936, T39904, T39889, T39845, T39781, T39827, T39828, T39779, T39769, T39705, T39693, T46365, T39689, T39969, T39670, T37168, T39651, T39625, T39585, T39529, T39518, T39448, T43296, T39443, T39372, T39374, T48363, T48364, T39351, T39326, T42812, T45718, T39313, T39285, T37755, T39933, T39281, T39290, T39267, T39268, T39270, T39271, T39143, T39096, T40101, T39085, T38193, T38203, T39523, T52610, T39081, T39076, T39077, T38984, T42103, T38945, T38450, T38434, T38197, T52651, T52652, T38185, T39530, T38180, T38133, T43455, T38103, T38151, T37879, T37845, T37831, T37830, T37824, T37813, T37800, T36459, T45354, T37780, T40096, T38205, T38206, T37779, T37725, T40124, T37705, T37634, T37589, T37461, T37280, T44750, T37251, T37231, T37216, T43744, T46725, T37200, T37193, T37153, T37058, T36679, T36657, T36614, T36528, T36512, T36513, T36514, T36516, T36517, T36504, T36501, T36458, T36463, T36376, T30914, T30912, T30847, T30851, T30852, T29965, T29964, T29955, T29954, T29953, T29936, T47918, T29935, T27236, T15775, T11827, T11589, T11422, T11297, T11214, T11215, T11614, T11201, T11202, T11213, T11419, T10102, T10131, T10089, T10098, T10099, T10101, T11165, T11166.
Root Cause
Process control
Action Taken
Inspire notified consignees on 07/31/2024, via emailed letter. Consignees were instructed to confirm the serial number on the lead is the serial number used to register the patient and to contact your Inspire representative if any labeling inconsistency is identified for complaint reporting.