Boston Scientific Neuromodulation Corporation: Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU

Recall number

Z-2694-2026

Recalling firm

Boston Scientific Neuromodulation Corporation

Product

Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU

Status

Open, Classified

Initiated

2026-04-22

Posted

2026-07-08

Terminated

not on file

Reason

Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.

Root cause

Packaging process control

Action

On 4/22/2026, removal notices were mailed to materials managers and health care professionals who were asked to do the following: 1) Segregate affected devices until they can be returned to firm. 2) Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 3) Forward this notice to any healthcare professional from your organization for awareness and to any organization to which affected devices have been transferred. 4) Complete and return the enclosed Reply Verification Tracking Form via email to BSCFieldActionCenter@bsci.com Any adverse events or quality concerns associated with use of these devices should be reported to firm via email at mailto: BSCcomplaints@bsci.com or

Quantity

37,764

Distribution

Worldwide - US Nationwide distribution including in the states of NJ, WI, MI, MN, AR, UT, OH, FL, CA, TX, PA, AZ, IN, LA, NE, OK, NY, MD, WY, CO, NC, IL, GA, WA, KS, AL, MO, VA, TN, KY, MS, MA, SC, OR, WV, MT, ID, SD, CT, NV, ND, NH, DE, NM, AK, IA, DC, HI, ME, VT, RI and the countries of Great Britain, Germany, United Arab Emirates.

Lot, serial or model codes

REF/UDI-DI/Lot/Expiration Date Range: RLV0035/852454006240/36231634, 36266333, 36266334, 36266335, 36442451, 36556998, 36577474, 36577475, 37355534, 37374614, 37642257, 37642258, 37667047, 37667049, 38711750, 38711751/04-Mar-2027 to 21-Jul-2027; RLV0035-EU/852454006448/36267790, 36909569, 38889437/04-Mar-2027 to 26-Jun-2027; RLV0045/852454006301/35218150, 35218151, 35218152, 35218153, 35219469, 35219470, 35229010, 35229011, 35229012, 35256597, 35318740, 35318741, 35318742, 35329853, 35329854, 35338734, 35360990, 35360991, 35360992, 35406849, 35406850, 35406851, 35406852, 35406853, 35406854, 35498172, 35508065, 35508066, 35523483, 35523484, 35525666, 35535444, 35535445, 35535446, 35535664, 35535665, 35536282, 35538112, 35538113, 35538114, 35538115, 35717797, 35717798, 35717861, 35729587, 35729588, 35729589, 35738091, 35738092, 35738093, 35755411, 35755412, 35755413, 35788378, 35788379, 35788400, 35789578, 35789579, 35789840, 35822293, 35822294, 35822295, 35831721, 35831722, 35831723, 35884013, 35884014, 35884015, 35884018, 35884019, 35884200, 35929731, 35929732, 35929733, 35939403, 35939404, 35939405, 36007510, 36051631, 36051632, 36051633, 36061072, 36061073, 36063527, 36115270, 36115271, 36162140, 36201849, 36211661, 36211662, 36247081, 36247082, 36247083, 36299784, 36299785, 36306155, 36306908, 36312074, 36312075, 36312076, 36327640, 36327641, 36334682, 36334683, 36334684, 36337568, 36337569, 36356333, 36368650, 36368651, 36390837, 36390839, 36390960, 36390962, 36390963, 36411346, 36440610, 36440611, 36451984, 36455377, 36455378, 36528101, 36538547, 36538548, 36554903, 36576169, 36576170, 36576171, 36578105, 36578106, 36578107, 36578108, 36709018, 36714451, 36719971, 36731035, 36731036, 36731037, 36733644, 36733645, 36743247, 36743248, 36765841, 36765842, 36765843, 36778439, 36779700, 36779701, 36789363, 36789364, 36793775, 36793776, 36802652, 36802653, 36802654, 36814178, 36819483, 36819484, 36825817, 36835476, 36839951, 36839952, 36892404, 36892405, 36907158, 36920578, 36931525, 36938443, 36938444, 36938445, 36948565, 36965128, 36977051, 36984738, 37006934, 37006935, 37021399, 37038790, 37060446, 37072745, 37072746, 37115658, 37126596, 37126597, 37143684, 37143685, 37182176, 37182177, 37191624, 37203924, 37210305, 37222391, 37222392, 37248543, 37248544, 37257912, 37278064, 37278065, 37291738, 37422836, 37422837, 37422838, 37434285, 37434286, 37443230,37467700, 37467701, 37467702, 37499290, 37499291, 37513740, 37513741, 37527332, 37558530, 37558531, 37586529, 37604798, 37604928, 37752893, 37752894, 37808050, 37808051, 37818544, 37818545, 37818546, 37864351, 37864352, 37876714, 37876715, 37876716, 37876717, 37909770, 37909771, 37923968, 37941727, 37941728, 38243913, 38243914, 38243915, 38253672, 38253673, 38253674, 38253675, 38257979, 38258120, 38258121, 38393517, 38393518, 38461277, 38461278, 38462080, 38462081, 38462082, 38462587, 38472779, 38473000, 38473001, 38473954, 38484605, 38484606, 38496711, 38517754, 38531680, 38600809, 38600810, 38600811, 38600812, 38632672, 38632673, 38632674, 38711753, 38712187, 38917000, 38917002, 39009366/03-Oct-2026 to 03-Mar-2028; RLV0045-EU/852454006431/36190488, 36254922, 36411351, 36909570, 37575379, 38654200/11-Feb-2027 to 04-Nov-2027; RLV0055/852454006226/35235794, 35235795, 35235796, 35235797, 35235798, 35235799, 35235940, 35244678, 35244679, 35245420, 35265922, 35309126, 35309128, 35309130, 35316016, 35328273, 35328274, 35367311, 35367312, 35367313, 35453674, 35461292, 35461293, 35461294, 35461295, 35461296, 35469325, 35469326, 35469327, 35498173, 35498174, 35508414, 35508415, 35516633, 35518863, 35518864, 35520116, 35522815, 35522816, 35522817, 35522818, 35530433, 35530434, 35582150, 35582151, 35582152, 35585353, 35585354, 35590649, 35590650, 35738094, 35738095, 35738096, 35738097, 35738098, 35738099, 35780448, 35780449, 35780450, 35789910, 35789911, 35789912, 35796422, 35796423, 35796424, 35831784, 35831785, 35831786, 35841864, 35841865, 35841866, 35849369, 35849370, 35849371.35871196, 35871197, 35871198, 35890764, 35890765, 35890766, 35989202, 35989203, 35989204, 36042033, 36042034, 36042035, 36051634, 36051635, 36051636, 36103927, 36103928, 36103930, 36168356, 36201850, 36254923, 36254924, 36258582, 36299786, 36299787, 36306157, 36306158, 36306159, 36315014, 36315015, 36327258, 36327259, 36334687, 36334688, 36334689, 36346737, 36346738, 36346739, 36346800, 36356510, 36356511, 36368652, 36368653, 36377745, 36421406, 36421407, 36421408, 36442449, 36442450, 36455379, 36466553, 36466554, 36474482, 36509579, 36509640, 36511507, 36518452, 36518454, 36519641, 36519642, 36538550, 36588268, 36588269, 36588270, 36588271, 36588273, 36627806, 36779702, 36779703, 36779704, 36789365, 36796277, 36796278, 36801923, 36879218, 36879219, 36879300, 36885626, 36885627, 36948834, 37018069, 37018070, 37021397, 37021398, 37030573, 37038794, 37060447, 37072747, 37072748, 37072749, 37085884, 37085885, 37097347, 37097348, 37097349, 37097352, 37105997, 37105998, 37114545, 37143682, 37143683, 37234124, 37234125, 37248545, 37266940, 37266941, 37278066, 37291818, 37291819, 37422839, 37423650, 37423651, 37434287, 37434288, 37476160, 37476161, 37486544, 37513375, 37513376, 37517300, 37527333, 37527334, 37527335, 37528240, 37528241, 37548528, 37548529, 37548530, 37548532, 37576081, 37586522, 37586530, 37597563, 37597564, 37606989, 37606990, 37606992, 37723478, 37752895, 37752896, 37752897, 37771990, 37771991, 37771993, 37772123, 37772124, 37772125, 37864353, 37864354, 37864355, 37885352, 37885353, 37930763, 37930764, 37930765, 37954165, 37954166, 37954167, 37954168, 38048470, 38196327, 38196328, 38243169, 38243170, 38252987, 38252988, 38252989, 38287216, 38287217, 38287218, 38404416, 38462594, 38474849, 38474880, 38474881, 38481950, 38481954, 38483325, 38496708, 38496709, 38529820, 38531658, 38531659, 38537775, 38540454, 38540782, 38540792, 38614681, 38711754, 38712189/10-Oct-2026 to 29-Oct-2027; RLV0055-EU/852454006318/36190489/30-Jan-2027 to 30-Jan-2027; RLV0065/852454006424/37166269, 37166270, 37205965, 37422790, 37422791, 37434847, 37434848, 37822997, 37822998, 37822999, 37837635, 37837636, 37837637, 37859920, 37903427, 37903428, 37909761, 37930774, 37930775, 37980230, 37980231, 37980232, 37980233, 38079204, 38079205, 38079206, 38079207, 38107765, 38107766, 38107767, 38107768, 38135922, 38135923, 38135924, 38154984, 38154985, 38159015, 38166823, 38166824, 38166825, 38166826, 38166827, 38166828, 38169819, 38170180, 38170693, 38170694, 38205657, 38205658, 38205659, 38222326, 38222327, 38222328, 38222329, 38222330, 38243916, 38339417, 38339418, 38339419, 38339880, 38339881, 38347588, 38355042, 38358582, 38358583, 38358584, 38360834, 38360835, 38366171, 38384137, 38384138, 38384139, 38392693, 38404412, 38404413, 38412000, 38412001, 38412003, 38412005, 38412006, 38412007, 38415242, 38415246, 38529822, 38531280, 38531281, 38559204, 38559205, 38559206, 38559207, 38568272, 38580272, 38580273, 38580274, 38580275, 38589983, 38589984, 38589985, 38590380, 38590381, 38590382, 38590383, 38590384, 38590385, 38590386, 38590387, 38590388, 38597090, 38623873, 38623874, 38623875, 38623876, 38632676, 38632678, 38643661, 38645060, 38645061, 38645062, 38645063, 38692073, 38692074, 38692075, 38692076, 38703597, 38708720, 38708721, 38708722, 38708723, 38712509, 38712511, 38712512, 38739451, 38739453, 38739454, 38739455, 38750004, 38750005, 38750007, 38774400, 38774401, 38802555, 38802556, 38802557, 38802558, 38809866, 38812686, 38812687, 38812688, 38821188, 38821189, 38821191, 38823209, 38823210, 38858563, 38858564, 38858565, 38858566, 38858570, 38869945, 38870375, 38870378, 38870783, 38870784, 38878535, 38878536, 38878538, 38878539, 38879225, 38879226, 38949331, 38949332, 38949333, 38949334, 39032543/30-Jul-2027 to 15-Mar-2028; RLV0075/852454006257/35490122, 35490123, 35490124, 35490125, 35490126, 35604788, 35615708, 35615709, 35705365, 35705366, 35901453, 35901454, 35901455, 35936488, 35936489, 35998826, 35998827, 35998828, 36159579, 36254921.36349203, 36349204, 36404502, 36404503, 36421409, 36835470, 36870653, 36870654, 36874432, 36874433, 36929050, 36929051, 36929052, 36929053, 36929054, 36983480, 36983481, 37060448, 37107838, 37107839, 37191554, 37191555, 37191556, 37204731, 37210306, 37335984, 37355535, 37364022, 37535449, 37535450, 37752898, 37943227, 37976478, 37976479, 37977720, 37977721, 38048471, 38179848, 38249218, 38249700, 38249991, 38253644, 38253645, 38253670, 38253671, 38347590, 38384136, 38426598, 38451722, 38451723, 38508092, 38529821, 38531016, 38539792, 38540765, 38540766, 38655662, 38730788, 38763797, 38763799/29-Oct-2026 to 21-Nov-2027; RLV0075-EU/852454006455/36267789, 36932250, 37575378/23-Jan-2027 to 14-Aug-2027

510(k) numbers

["K222281"]

PMA numbers

not on file

Product code

GXI

Firm FEI

3006630150

Firm city

Valencia

Firm state

CA

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