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AMS 700 LGX TENACIO Pump recallZ-0144-2026 · Boston Scientific Corporation · initiated Sep 11, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On September 11, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: For implanted devices: If the device is working properly, no action is required. Further evaluation is recommended for patients who were implanted with an affected device AND are having difficulty inflating or deflating the device. - Check inventory for affected product and return any unused devices. Immediately cease further distribution or use of any unused affected devices. Please pass this notice to any healthcare professional from your organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Please provide Boston Scientific with details of any affected devices that have been transferred to another organization.

Recall details

Recall number
Z-0144-2026
Status
Open, Classified
Initiated by the company
Sep 11, 2025
Posted by the FDA
Oct 10, 2025
Recalling firm
Boston Scientific Corporation
Quantity
490 units
Product code
JCW
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

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);

Code information (models, lots, serial numbers)

Show the full code information (10k characters)

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;

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97603).

Sources and updates

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