PELIGROSO · Class I
Dejar de usar inmediatamente
*Sistema de Entrega Mejorado por Electrocauterio y Stent HOT AXIOS 20mm x 10mm; Número de Material (UPN): M00553560;
🔍 ¿Tu lote está aquí?
Revisa el envase de tu producto y compara con estos números.
¿Qué pasó?
Aumento en los informes de problemas con el despliegue y expansión del stent. El resultado más común razonablemente previsible que resulta de la dificultad para desplegar el stent es la prolongación del procedimiento para intercambiar el dispositivo por uno nuevo. El resultado más serio razonablemente previsible en casos donde la primera brida no puede desplegarse o expandirse sería una cascada de eventos que resulten en una intervención adicional, ya sea endoscópica o quirúrgica, para remover el stent y cerrar el sitio de punción.
🛡️ ¿Qué hago ahora?
- 1Verifica el número de lote en el envase del producto.
- 2Si lo tienes, no lo uses.
- 3Devuélvelo a tu farmacia o al lugar donde lo compraste para reembolso.
- 4Si ya lo usaste y te sientes mal, ve a tu médico inmediatamente.
- 5Reporta efectos adversos a la FDA: 1-800-FDA-1088.
📋 Números de lote afectados (datos completos)
Material Number (UPN): M00553560; UDI-DI: 8714729951100; Lot Numbers: 35793920, 35952745, 35961004, 35995006, 35995007, 35995165, 36001950, 36001951, 36001952, 36001953, 36002902, 36002903, 36002904, 36003946, 36003947, 36003948, 36012845, 36012846, 36012847, 36012848, 36015761, 36021049, 36021050, 36021051, 36021052, 36027054, 36027055, 36027056, 36027057, 36027058, 36027059, 36027060, 36027061, 36038410, 36038411, 36040000, 36040001, 36040002, 36040003, 36040004, 36048795, 36048796, 36048797, 36048798, 36049282, 36049283, 36049284, 36050387, 36050388, 36050389, 36059222, 36059223, 36059224, 36059225, 36062077, 36062078, 36062079, 36064449, 36065116, 36065117, 36067962, 36067963, 36067964, 36069958, 36069959, 36070600, 36070608, 36070609, 36070610, 36070611, 36072736, 36072737, 36092333, 36092334, 36092335, 36099411, 36099412, 36099413, 36101743, 36101744, 36101745, 36101746, 36101747, 36102812, 36102813, 36102814, 36135590, 36135591, 36144122, 36144123, 36147096, 36147097, 36154534, 36154536, 36154537, 36154538, 36155116, 36155117, 36156264, 36156265, 36164534, 36164535, 36164536, 36165655, 36165656, 36165657, 36165658, 36197586, 36197587, 36197588, 36197589, 36199391, 36200602, 36200603, 36207756, 36207757, 36207758, 36209378, 36209379, 36218689, 36218690, 36218746, 36218747, 36219228, 36271447, 36271448, 36271456, 36271457, 36271458, 36271459, 36271840, 36303991, 36303992, 36303993, 36310699, 36310760, 36310761, 36310762, 36310763, 36310764, 36310765, 36310766, 36310767, 36310768, 36310769, 36447543, 36447544, 36447545, 36447546, 36449567, 36449568, 36458833, 36458834, 36461125, 36478581, 36478582, 36478583, 36478584, 36478585, 36481333, 36481334, 36487762, 36487763, 36487764, 36487765, 36493311, 36493313, 36493314, 36494812, 36494813, 36503314, 36503315, 36503316, 36503317, 36503459, 36504640, 36504702, 36509327, 36517739, 36517821, 36517822, 36519644, 36533327, 36533328, 36548037, 36548038, 36548039, 36548060, 36548061, 36551002, 36551003, 36551004, 36559039, 36559580, 36559581, 36559582, 36559583, 36560842, 36560843, 36562844, 36562845, 36565931, 36566528, 36567449, 36570785, 36570786, 36570787, 36572359, 36581587, 36583578, 36583579, 36591069, 36591070, 36591071, 36591072, 36612260, 36612261, 36616444, 36616445, 36619789, 36619790, 36619791, 36619792, 36619793, 36621321, 36621322, 36621323, 36625032, 36625033, 36625034, 36625035, 36626350, 36626351, 36626352, 36633245, 36633246, 36640831, 36641049, 36641909, 36641910, 36642073, 36642074, 36642075, 36642562, 36643731, 36643732, 36645532, 36645533, 36645534, 36647015, 36662774, 36662775, 36662776, 36662778, 36662779, 36664061, 36664062, 36664063, 36664064, 36664065, 36664567, 36664568, 36664794, 36664796, 36665694, 36665695, 36669412, 36669413, 36669414, 36669415, 36669416, 36669417, 36669418, 36674810, 36674811, 36674812, 36674813, 36677847, 36683263, 36684615, 36685905, 36685906, 36804376, 36814735, 36816919, 36818381, 36818382, 36821877, 36823193, 36823194, 36828324, 36828325, 36829194, 36829196, 36835382, 36835383, 36838544, 36838545, 36838546, 36838547, 36839663, 36839664, 36847979, 36848665, 36848666, 36851793, 36851794, 36853105, 36853106, 36853594, 36853595, 36854299, 36856185, 36856186, 36856187, 36856188, 36856340, 36856341, 36856342, 36866851, 36866852, 36866853, 36868980, 36868981, 36868982, 36868983, 36868984, 36869884, 36869885, 36869886, 36869887, 36869888, 36869889, 36869890, 36869891, 36875736, 36875737, 36877081, 36877082, 36877084, 36877085, 36880763, 36880764, 36897772, 36897773, 36959806, 36959807, 36994050, 36994051, 36994052, 36995011, 36995012, 36999167, 36999494, 37004725, 37004726, 37004727, 37059011, 37060652, 37067633, 37069356, 37069357, 37075264, 37075265, 37078233, 37078234, 37093209, 37093210, 37093302, 37093303, 37096513, 37096514, 37099739, 37132500, 37132501, 37132502, 37134087, 37137422, 37137423, 37140068, 37152588, 37153325, 37157514, 37161889, 37161890, 37164067, 37164068, 37167102, 37167103, 37167775, 37176653, 37176657, 37194095, 37204177, 37204178, 37204179, 37204240, 37204241, 37204809, 37204810, 37204811, 37207470, 37207471, 37208948, 37217600, 37217605, 37217607, 37240010, 37240011, 37252330, 37252331, 37252333, 37252334, 37252335, 37257420, 37257421, 37257422, 37257423, 37261686, 37262942, 37262943, 37262949, 37262950, 37263184, 37263185, 37263554, 37263555, 37268080, 37268081, 37268098, 37269066, 37269067, 37269068, 37272106, 37272107, 37272903, 37272904, 37273840, 37273841, 37274479, 37274863, 37275620, 37276239, 37276361, 37276363, 37276364, 37308911, 37323226, 37323227, 37323228, 37323229, 37324379, 37325180, 37325181, 37325182, 37325354, 37331113, 37379513, 37380940, 37380941, 37380942, 37382298, 37382299, 37384504, 37384505, 37386277, 37386278, 37443960, 37443961, 37443962, 37451306, 37451307, 37456598, 37457260, 37460647, 37460648, 37461035, 37461036, 37463128, 37463129, 37501715, 37501716, 37501717, 37510239, 37511240, 37514184, 37514185, 37514972, 37524755, 37524756, 37524758, 37530261, 37536574, 37538606, 37541652, 37543964, 37543965, 37543966, 37544646, 37544647, 37544648, 37548357, 37548358, 37549491, 37549492, 37552245, 37552246, 37552247, 37552248, 37554898, 37567401, 37567402, 37567403, 37567404, 37567405, 37567406, 37601264, 37601265, 37601266, 37611305, 37611306, 37611307, 37611308, 37617701, 37617702, 37625483, 37625484, 37644410, 37649490, 37651467, 37655139, 37655280, 37655281, 37660774, 37660775, 37660777, 37660778, 37665497, 37667998, 37672121, 37675664, 37675665, 37689944, 37689945, 37696688, 37720785, 37723579, 37731195, 37731196, 37731197, 37742018, 37745174, 37746915, 37750340, 37750341, 37754384, 37754385, 37755928, 37755939, 37771352, 37771353, 37771354, 37771355, 37777208, 37778063, 37780175, 37780176, 37809876, 37809877, 37809878, 37809879, 37811060, 37811061, 37811062, 37811063, 37817124, 37817482, 37817483, 37820575, 37820576, 37820577, 37837386, 37837890, 37837891, 37844022, 37846410, 37846411, 37846412;
- Empresa
- Boston Scientific Corporation
- Estatus
- Ongoing
- Fecha del reporte
- 2026-02-11
- Iniciado
- 2025-12-19
- Distribución
- Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.
- Cantidad
- 588 units
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