Boston Scientific Corporation
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
1. UPN: 72404450 (12CM PS IZ); UDI-DI: 00191506021412; Lot numbers: 1100404813, 1100404817, 1100404818, 1100404819, 1100404820, 1100404821, 1100558512, 1100565086, 1100568924, 1100585061, 1100596471, 1100596473, 1100617027, 1100404816, 1100404814, 1100404815, 1100558509, 1100512315, 1100565093, 1100512387, 1100565088, 1100558508, 1100512313, 1100512388, 1100565084, 1100568927, 1100568926, 1100611812, 1100585059, 1100596478, 1100598982, 1100611809, 1100596324, 1100596477, 1100596472, 1100579740, 1100585066, 1100585064, 1100579739, 1100619111, 1100626304, 1100611810, 2. UPN: 72404451 (15CM PS IZ); UDI-DI: 00191506021429; Lot numbers: 1100480113, 1100480114, 1100480115, 1100480117, 1100480622, 1100480623, 1100480624, 1100480625, 1100480626, 1100480627, 1100480628, 1100511666, 1100511668, 1100511669, 1100511671, 1100511673, 1100558263, 1100558264, 1100558265, 1100563672, 1100563673, 1100563674, 1100563676, 1100563679, 1100563680, 1100584476, 1100584477, 1100584479, 1100584481, 1100584482, 1100584483, 1100592722, 1100592723, 1100592724, 1100592725, 1100592726, 1100592728, 1100595757, 1100595758, 1100595762, 1100595763, 1100595764, 1100595785, 1100595786, 1100595787, 1100595788, 1100609511, 1100609512, 1100609514, 1100613865, 1100613869, 1100613870, 1100613871, 1100613872, 1100613873, 1100614058, 1100614059, 1100614061, 1100614062, 1100614063, 1100614064, 1100614065, 1100615565, 1100615568, 1100615571, 1100615572, 1100615573, 1100636975, 1100636981, 1100636982, 1100636983, 1100656099, 1100656107, 1100666343, 1100666344, 1100666347, 1100666352, 1100670774, 1100670779, 1100683615, 1100683617, 1100683618, 1100683621, 1100685703, 1100685751, 1100685752, 1100686397, 1100686399, 1100686405, 1100687070, 1100687079, 1100692405, 1100692409, 1100695717, 1100695719, 1100695720, 1100695723, 1100723763, 1100723774, 1100563677, 1100558258, 1100592721, 1100609517, 1100592727, 1100595761, 1100609513, 1100636980, 1100614060, 1100614066, 1100636978, 1100592729, 1100584478, 1100584475, 1100595760, 1100595789, 1100615566, 1100695718, 1100666350, 1100656100, 1100685758, 1100656103, 1100685705, 1100685756, 1100666346, 1100692404, 1100685708, 1100695722, 1100692403, 1100685702, 1100656104, 1100685701, 1100656102, 1100685755, 1100692401, 1100656105, 1100686403, 1100723777, 3. UPN: 72404452 (18CM PS IZ); UDI-DI: 00191506021436; Lot numbers: 1100480677, 1100480678, 1100480679, 1100480680, 1100480681, 1100480683, 1100480684, 1100480685, 1100481060, 1100481061, 1100481062, 1100481063, 1100481064, 1100481065, 1100481066, 1100481067, 1100481068, 1100481069, 1100489331, 1100489333, 1100489334, 1100489335, 1100489336, 1100489337, 1100489338, 1100489339, 1100489340, 1100489401, 1100489402, 1100489403, 1100489404, 1100489405, 1100489406, 1100489407, 1100489408, 1100509667, 1100509668, 1100509669, 1100509670, 1100509671, 1100509672, 1100509673, 1100509674, 1100509675, 1100509676, 1100526020, 1100526022, 1100526023, 1100526024, 1100526025, 1100526026, 1100526027, 1100527427, 1100527428, 1100527430, 1100527431, 1100527432, 1100527433, 1100527434, 1100534298, 1100534299, 1100534300, 1100534301, 1100534302, 1100534303, 1100534304, 1100534305, 1100534306, 1100534307, 1100563839, 1100563840, 1100563841, 1100563842, 1100563843, 1100563844, 1100563845, 1100563847, 1100573665, 1100573666, 1100573668, 1100573669, 1100573670, 1100573671, 1100573672, 1100573673, 1100578326, 1100578327, 1100578328, 1100578329, 1100578330, 1100578332, 1100578333, 1100578334, 1100578335, 1100582002, 1100582004, 1100582005, 1100582006, 1100582008, 1100582009, 1100582011, 1100582030, 1100582031, 1100582033, 1100582034, 1100591038, 1100591039, 1100591040, 1100591041, 1100591043, 1100591044, 1100591045, 1100591046, 1100591047, 1100614940, 1100614941, 1100614942, 1100614944, 1100614946, 1100614947, 1100614948, 1100614949, 1100614970, 1100614972, 1100614973, 1100614974, 1100614975, 1100614976, 1100614977, 1100614978, 1100614979, 1100615058, 1100615059, 1100615060, 1100615061, 1100615062, 1100615063, 1100615064, 1100620589, 1100620590, 1100620591, 1100620595, 1100620596, 1100620597, 1100622718, 1100622721, 1100622722, 1100622724, 1100622726, 1100625061, 1100625062, 1100625063, 1100625064, 1100625065, 1100625067, 1100625068, 1100654712, 1100654714, 1100654718, 1100654719, 1100654720, 1100657159, 1100657160, 1100657161, 1100657162, 1100660268, 1100660270, 1100660271, 1100660272, 1100660274, 1100665201, 1100665202, 1100665207, 1100665208, 1100665209, 1100665211, 1100665216, 1100665218, 1100665219, 1100665220, 1100666171, 1100666173, 1100666174, 1100666175, 1100666176, 1100666177, 1100666178, 1100666179, 1100666180, 1100666182, 1100666183, 1100666184, 1100666185, 1100669329, 1100669332, 1100669333, 1100669335, 1100669337, 1100669338, 1100670829, 1100670830, 1100670831, 1100670832, 1100670833, 1100683504, 1100683506, 1100683507, 1100683509, 1100683510, 1100683511, 1100683909, 1100683910, 1100683912, 1100683913, 1100683915, 1100683916, 1100683917, 1100683918, 1100687319, 1100687322, 1100687324, 1100687325, 1100687929, 1100687930, 1100687932, 1100687933, 1100687934, 1100687936, 1100687937, 1100687938, 1100690681, 1100690682, 1100690684, 1100690686, 1100690688, 1100691647, 1100691648, 1100691649, 1100691652, 1100697431, 1100697432, 1100697433, 1100697434, 1100710464, 1100710471, 1100710472, 1100710473, 1100489332, 1100527429, 1100573674, 1100480676, 1100591042, 1100582032, 1100654717, 1100654715, 1100654716, 1100614943, 1100582007, 1100620594, 1100665203, 1100666169, 1100665212, 1100690683, 1100657158, 1100666170, 1100683914, 1100687318, 1100687931, 1100660269, 1100683505, 1100665206, 1100660275, 1100690685, 1100697436, 1100666172, 1100691656, 1100660273, 1100683512, 1100657163, 1100710468, 4. UPN: 72404453 (21CM PS IZ); UDI-DI: 00191506021443; Lot numbers: 1100527254, 1100527256, 1100547607, 1100547610, 1100547613, 1100547615, 1100553676, 1100553680, 1100615799, 1100615802, 1100615806, 1100615807, 1100615808, 1100627337, 1100627340, 1100628656, 1100628657, 1100628658, 1100628659, 1100632123, 1100632124, 1100636857, 1100678269, 1100687081, 1100687084, 1100713232, 1100547611, 1100527260, 1100527263, 1100542413, 1100553678, 1100542412, 1100628651, 1100615800, 1100615805, 1100636859, 1100636860, 1100615801, 1100628655, 1100636864, 1100628650, 1100627339, 1100636865, 1100636862, 1100678264, 1100678267, 1100692151, 1100687083, 1100692146, 5. UPN: 72404455 (12CM IP IZ); UDI-DI: 00191506021450; Lot numbers: 1100491487, 1100573783, 1100581262, 1100581263, 1100581266, 1100581297, 1100573778, 1100573776, 1100573782, 1100491491, 1100569277, 1100573781, 1100491492, 1100570202, 1100491486, 1100596863, 1100581305, 1100596861, 1100581304, 1100596862, 1100581306, 1100581300, 1100584903, 1100596864, 1100581271, 1100596858, 1100581302, 1100581269, 1100584900, 1100581301, 1100584899, 1100581267, 1100584897, 1100679354, 1100679350, 6. UPN: 72404456 (15CM IP IZ); UDI-DI: 00191506021467; Lot numbers: 1100481228, 1100481229, 1100481230, 1100481231, 1100481233, 1100481234, 1100481235, 1100481237, 1100629264, 1100629272, 1100629273, 1100651201, 1100651205, 1100651210, 1100651212, 1100651213, 1100651214, 1100651215, 1100655196, 1100668323, 1100668324, 1100670786, 1100670790, 1100673337, 1100673338, 1100673343, 1100673344, 1100676819, 1100690779, 1100690780, 1100690787, 1100690790, 1100716504, 1100716521, 1100481236, 1100481232, 1100629266, 1100651211, 1100651209, 1100655194, 1100655202, 1100651204, 1100655197, 1100655193, 1100651203, 1100651217, 1100676816, 1100690792, 1100668322, 1100690783, 1100690794, 1100676817, 1100670788, 1100670785, 1100716522, 1100716514, 1100716509, 1100716512, 7. UPN: 72404457 (18CM IP IZ); UDI-DI: 00191506021474; Lot numbers: 1100398489, 1100398490, 1100398491, 1100398492, 1100398493, 1100398494, 1100398495, 1100398496, 1100481311, 1100481312, 1100481314, 1100481316, 1100481317, 1100481318, 1100481319, 1100481320, 1100535385, 1100535386, 1100535387, 1100535388, 1100535389, 1100535390, 1100535391, 1100535392, 1100613884, 1100613885, 1100613886, 1100613887, 1100613888, 1100613889, 1100613890, 1100613891, 1100613892, 1100629807, 1100629809, 1100629810, 1100629811, 1100629812, 1100629813, 1100629814, 1100651802, 1100651803, 1100651804, 1100651808, 1100651837, 1100651838, 1100651839, 1100651840, 1100651845, 1100655625, 1100655626, 1100655627, 1100655628, 1100655629, 1100655631, 1100655632, 1100655633, 1100655634, 1100655710, 1100655711, 1100655712, 1100655713, 1100655716, 1100655717, 1100655718, 1100657357, 1100657358, 1100657359, 1100657361, 1100657364, 1100667614, 1100667615, 1100667616, 1100667617, 1100667618, 1100667619, 1100667620, 1100667623, 1100667624, 1100667626, 1100667627, 1100667628, 1100667631, 1100668311, 1100668313, 1100668315, 1100668316, 1100668317, 1100695663, 1100695665, 1100712622, 1100712630, 1100714749, 1100726414, 1100726417, 1100726418, 1100726419, 1100481315, 1100481313, 1100651807, 1100655714, 1100655709, 1100667613, 1100695659, 1100667630, 1100657360, 1100668312, 1100695666, 1100668318, 1100714743, 1100714751, 1100714748, 1100726416, 1100712631, 8. UPN: 72404458 (21CM IP IZ); UDI-DI: 00191506021481; Lot numbers: 1100401206, 1100401207, 1100401208, 1100401209, 1100401210, 1100401211, 1100401212, 1100401213, 1100401214, 1100527092, 1100527095, 1100527100, 1100538045, 1100545960, 1100545961, 1100545968, 1100556132, 1100556135, 1100556136, 1100579477, 1100579479, 1100579480, 1100579482, 1100579483, 1100579488, 1100579494, 1100603659, 1100603662, 1100620429, 1100620431, 1100621446, 1100621448, 1100621450, 1100658988, 1100658995, 1100658996, 1100688010, 1100688011, 1100688012, 1100579484, 1100579493, 1100556134, 1100579478, 1100579487, 1100579491, 1100556137, 1100579476, 1100527096, 1100579489, 1100527097, 1100556138, 1100603665, 1100603658, 1100603661, 1100621451, 1100621443, 1100621449, 1100621445, 1100636814, 1100603660, 1100658991, 1100688007, 1100658989, 1100658997, 1100688008, 1100688005;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →