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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2694-2026

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

Publicado el 15 de julio de 2026 · Inicio del retiro: 22 de abril de 2026

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Boston Scientific Neuromodulation Corporation
Distribuidor
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.
Lote
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,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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