Inspire Medical Systems Inc.: Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Recall number

Z-0041-2025

Recalling firm

Inspire Medical Systems Inc.

Product

Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Status

Open, Classified

Initiated

2024-07-31

Posted

2024-10-09

Terminated

not on file

Reason

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Root cause

Process control

Action

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.

Quantity

457 units

Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

MNQ

Firm FEI

3007666314

Firm city

Golden Valley

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy