Cook Inc.: Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98

Recall number

Z-1844-2019

Recalling firm

Cook Inc.

Product

Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98

Status

Terminated

Initiated

2019-04-26

Posted

2019-06-19

Terminated

2019-11-08

Reason

may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.

Root cause

Under Investigation by firm

Action

Urgent Medical Device Recall notification letters dated 4/26/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns, contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.

Quantity

1027

Distribution

No US distribution. Product distributed to the following foreign countries: Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

Lot, serial or model codes

9221784, 9228731, 9232249, 9246529, 9272685, 9272835, 9276029, 9276400, 9303245, 9373623, 9406776, 9466908, 9506559, 9525188, 9557569, 9566160, 9566211, 9575380, 9620378, 9620379, 9620382, 9625916, 9625917, 9636371, 9640584, 9663986 9406777, 9522416, 9566161, 9575382, 9625918, 9656992 9557570, 9566162, 9575383, 9625919, 9625920, 9656978 9221629, 9232247, 9276401, 9303246, 9373624, 9394051, 9403262, 9406778, 9406779, 9406780, 9453299, 9466909, 9466910, 9482147, 9486290, 9486313, 9506616, 9522418, 9522419, 9525189, 9529047, 9534284, 9555442, 9555453, 9555475, 9566214, 9572229, 9575386, 9592482, 9592485, 9594196, 9594205, 9609105, 9617443, 9617445, 9625921, 9625922, 9625923, 9636298, 9636330, 9640585, 9642977, 9650113, 9650114, 9394051X, NS9584273, NS9584274, NS9584275, NS9584276, NS9584277, NS9584278, NS9584279, NS9584280, NS9584281, NS9584282 9214951, 9221781, 9221785, 9221786, 9221787, 9228739, 9232238, 9232239, 9232250, 9234942, 9239302, 9239303, 9246530, 9272665, 9272686, 9272687, 9272836, 9276402, 9276403, 9391303, 9403123, 9403124, 9403125, 9403126, 9403127, 9403128, 9403129, 9403130, 9403131, 9403132, 9403133, 9403134, 9403136, 9403137, 9403138, 9403139, 9404632, 9404633, 9406719, 9406720, 9406721, 9406781, 9406782, 9406783, 9464235, 9522423, 9529049, 9529050, 9529051, 9557572, 9561001, 9566215, 9575388, 9581884, 9594197, 9594206, 9598741, 9602905, 9605694, 9605695, 9625893, 9625896, 9625924, 9625925, 9625926, 9636372, 9640586, 9642978, 9656979, 9656994, 9272665X, 9403130X, 9522423X, NS9239300, NS9239301 9221788, 9289544, 9373625, 9406785, 9419801, 9482149, 9515085, 9557563, 9557573, 9561002, 9566216, 9572230, 9575390, 9594207, 9602906, 9605689, 9605696, 9611316, 9617447, 9620383, 9625897, 9625927, 9625928, 9629883, 9629884, 9640587, 9640588, 9653876, 9656980, 9671098 9228740, 9242449, 9386592, 9386660, 9386661, 9386662, 9466913, 9466914, 9466915, 9605686, 9623874, 9623879, 9625845, 9640513, 9640514, 9671040, 9671042, 9671043, 9671044, 9242450 9228741, 9228742, 9403263, 9419802, 9470240, 9506618, 9515086, 9557574, 9561003, 9566217, 9575392, 9609106, 9623930, 9625929, 9629885, 9640589, 9640590, 9656981, 9660204, 9663989 9373626, 9557564, 9557575, 9569073, 9575332, 9578369, 9629871, 9629886, 9640591, 9656995, 9373626X 8405214, 9221798, 9221799, 9226415, 9226416, 9226417, 9228743, 9232252, 9239304, 9242451, 9248832, 9248833, 9248834, 9276031, 9276032, 9276406, 9276407, 9276408, 9276409, 9303242, 9373627, 9373628, 9409576, 9419022, 9442622, 9464237, 9470243, 9470244, 9470245, 9482150, 9486314, 9486315, 9508711, 9508712, 9508713, 9515058, 9515059, 9515060, 9515088, 9515089, 9515090, 9515091, 9515092, 9522430, 9522431, 9522432, 9522433, 9529053, 9529054, 9557576, 9557577, 9566163, 9569089, 9578373, 9581886, 9584296, 9602907, 9602908, 9602909, 9602910, 9602911, 9617436, 9617449, 9617451, 9617453, 9617455, 9617458, 9620384, 9625898, 9629838, 9629839, 9629872, 9629873, 9629874, 9629875, 9629876, 9629887, 9629888, 9636331, 9636332, 9636333, NS9584286, NS9584287, NS9584288, NS9584289, NS9584290, NS9584291, NS9584292, NS9584293, NS9584294, NS9584295 9226360, 9226418, 9226420, 9226421, 9226422, 9226424, 9226425, 9226426, 9226427, 9228744, 9228745, 9228827, 9232253, 9239284, 9242433, 9242452, 9242453, 9242454, 9242455, 9242456, 9246532, 9246533, 9246534, 9246535, 9246536, 9386666, 9391304, 9391324, 9391325, 9391326, 9391327, 9391454, 9391455, 9391456, 9394052, 9394053, 9403264, 9403265, 9403266, 9419025, 9419026, 9419027, 9456698, 9464238, 9470209, 9470211, 9470246, 9470247, 9470248, 9474588, 9474589, 9474590, 9478694, 9478695, 9482116, 9486316, 9486324, 9506565, 9506566, 9506567, 9506568, 9508715, 9508716, 9508717, 9508718, 9508719, 9508720, 9508721, 9508722, 9512198, 9517953, 9517954, 9525193, 9525194, 9529058, 9529060, 9561004, 9569074, 9569095, 9575333, 9578381, 9598744, 9598745, 9598747, 9602912, 9602913, 9605697, 9623931, 9625899, 9629877, 9629889, 9640556, 9640557, 9640592, 9640593, 9640594, 9640595, 9640596, 9640597, 9640598, 9640599, 9642979, 9642980, 9647086, 9647087, 9650115, 9656963, 9656982, 9228745X, 9391324X, 9470248X, NS9584297, NS9584298, NS9584299, NS9584300, NS9584301, NS9584302, NS9584303, NS9584304, NS9584305, NS9584306 9228746, 9228748, 9232388, 9246537, 9246538, 9246539, 9246540, 9300906, 9303247, 9303248, 9303249, 9303281, 9370215, 9373476, 9373636, 9373638, 9391459, 9391460, 9391461, 9391462, 9403267, 9419029, 9419030, 9419031, 9419032, 9419033, 9419804, 9474595, 9486326, 9486327, 9486328, 9515098, 9515099, 9515100, 9515101, 9522445, 9522446, 9522447, 9522448, 9522449, 9529061, 9529062, 9529064, 9561005, 9566164, 9578386, 9581891, 9581892, 9587377, 9587406, 9647037, 9650044, 9650045, 9373637X 9217948, 9217949, 9217950, 9226365, 9228749, 9228750, 9246541, 9246542, 9246543, 9248835, 9248836, 9373644, 9391463, 9391464, 9394054, 9394055, 9403268, 9403269, 9403270, 9474596, 9525196, 9529066, 9529067, 9529068, 9534296, 9534297, 9557578, 9602871, 9650039, 9650040 9232389, 9246544, 9525197, 9525198, 9566166, 9578388, 9587407, 9625900, 9629891, 9640558, 9642981 9228753, 9232390, 9248837, 9396561, 9525171, 9525200, 9525202, 9557579, 9566167, 9578390, 9594198, 9594209, 9594210, 9629892, 9629893, 9640600, 9642982, 9642983, 9660205, 9664012 9226366, 9228755, 9228756, 9246545, 9246546, 9246547, 9246548, 9272837, 9276416, 9276417, 9300916, 9370209, 9370220, 9370221, 9370222, 9391465, 9391466, 9391467, 9464239, 9474597, 9474598, 9486330, 9506569, 9508723, 9508724, 9508725, 9529069, 9529070, 9566168, 9569103, 9569104, 9569105, 9578391, 9578392, 9581895, 9581896, 9581897, 9584308, 9584309, 9587408, 9598750, 9598751, 9602914, 9611317, 9617464, 9617466, 9617468, 9623932, 9625894, 9625901, 9629894, 9629895, 9629896, 9629897, 9629898, 9640559, 9640560, 9642967, 9642984, 9642985, 9642986, 9642987, 9642988, 9650116, 9653828, 9653858, 9653877, 9653878, 9653879, 9653880, 9656983 9217952, 9228734, 9228828, 9228829, 9228830, 9228831, 9228832, 9228833, 9228834, 9228835, 9228836, 9228837, 9232391, 9232392, 9234943, 9246549, 9246550, 9248838, 9279007, 9300908, 9300913, 9300917, 9303251, 9303283, 9303284, 9370225, 9380032, 9391468, 9391469, 9394056, 9394185, 9394186, 9394187, 9403271, 9403272, 9403273, 9403274, 9403275, 9409622, 9409623, 9419805, 9419807, 9456708, 9456713, 9470212, 9474599, 9474748, 9474749, 9474750, 9474751, 9474752, 9474753, 9506570, 9506571, 9506572, 9508726, 9508727, 9508728, 9508729, 9508730, 9508731, 9508732, 9508733, 9515108, 9515109, 9515110, 9515111, 9515112, 9515113, 9515114, 9525207, 9525208, 9525210, 9557580, 9620332, 9640511, 9642954, 9642955, 9650041, 9671028, 9394185X 9217983, 9217984, 9228735, 9228838, 9228839, 9228840, 9228841, 9228842, 9228843, 9232393, 9232394, 9248839, 9248840, 9272838, 9383423, 9394035, 9394190, 9394191, 9394192, 9394193, 9394194, 9394195, 9396562, 9404637, 9404638, 9404639, 9404640, 9404641, 9447170, 9464240, 9470213, 9470214, 9470215, 9470216, 9474754, 9474755, 9474756, 9474757, 9474758, 9474759, 9482118, 9508734, 9508735, 9515115, 9515116, 9515117, 9515118, 9515119, 9525214, 9525216, 9525218, 9525220, 9525221, 9529071, 9529072, 9529073, 9529074, 9529075, 9557581, 9566170, 9569110, 9572234, 9578357, 9578394, 9578395, 9578396, 9578397, 9578398, 9578399, 9578400, 9581898, 9581899, 9581900, 9587409, 9594199, 9594211, 9594212, 9594213, 9594214, 9594215, 9594216, 9598726, 9598727, 9598752, 9602915, 9602916, 9602917, 9602918, 9602919, 9602920, 9602921, 9609107, 9609108, 9611318, 9617479, 9617481, 9617483, 9617485, 9617488, 9625902, 9629899, 9629900, 9629901, 9629902, 9629903, 9629904, 9629905, 9629906, 9633300, 9633301, 9636334, 9636335, 9640561, 9642989, 9642990, 9642991, 9642992, 9642993, 9647088, 9647089, 9647090, 9647091, 9647092, 9650117, 9650118, 9650119, 9653859, 9653874, 9653881, 9656984, 9671059, 9671101, 9671102, 9671103, 9671104 9370226, 9376518, 9386593, 9386594, 9394036, 9394037, 9394197, 9394198, 9394199, 9394200, 9394201, 9394202, 9470217, 9470218, 9478696, 9478697, 9486297, 9508741, 9512199, 9515122, 9515123, 9515124, 9522377, 9525227, 9525229, 9525231, 9525233, 9529077, 9529078, 9529079, 9561008, 9566171, 9569113, 9578405, 9587415, 9594217, 9602922, 9602923, 9602924, 9605698, 9605699, 9605701, 9605702, 9609109, 9611319, 9617490, 9620385, 9620386, 9623933, 9629878, 9629907, 9636336, 9636337, 9636338, 9640562, 9640563, 9642968, 9642994, 9642995, 9647093, 9650120, 9660206, 9660207, 9660208, 9660209, 9660210 9279021, 9279022, 9279023, 9279024, 9394203, 9522378, 9529009, 9560984, 9561009, 9566172, 9569116, 9575338, 9578408, 9587417, 9594218, 9605703, 9609099, 9609110, 9611320, 9620387, 9620388, 9629908, 9636339, 9640564, 9642969, 9642996, 9642997, 9650121, 9650122, 9653882, 9656985, 9671105, 9671106, 9370227, 9370227X 9279025, 9370228, 9370229, 9400627, 9508744, 9515126, 9515127, 9534247, 9557565, 9560985, 9566173, 9575339, 9578409, 9578411, 9581849, 9587419, 9620389, 9633333, 9642970, 9647072, 9647095, 9650123, 9650124, 9656964, 9330485, 9330485X 9279026, 9279027, 9386653, 9478700, 9482119, 9486299, 9508745, 9508746, 9508747, 9515128, 9515129, 9515130, 9515131, 9522379, 9525248, 9534303, 9534304, 9566174, 9566175, 9569119, 9569122, 9569123, 9578412, 9578413, 9578414, 9578415, 9578416, 9578417, 9578418, 9587421, 9587422, 9594219, 9598729, 9602925, 9602926, 9602927, 9602928, 9602930, 9605704, 9623925, 9623926, 9623934, 9623935, 9623936, 9623937, 9633334, 9636299, 9636340, 9636341, 9636342, 9636343, 9640565, 9640566, 9647073, 9647074, 9647097, 9647098, 9647099, 9647100, 9656986, 9515130X 9276033, 9276034, 9279028, 9279110, 9279118, 9279119, 9279121, 9279122, 9279123, 9279124, 9279125, 9279126, 9279127, 9365243, 9365244, 9365245, 9370230, 9370231, 9370232, 9370238, 9370239, 9370240, 9370241, 9370242, 9386654, 9461549, 9461553, 9464246, 9466882, 9470221, 9470222, 9474577, 9474578, 9478701, 9478702, 9478703, 9478704, 9478705, 9478706, 9478707, 9478708, 9478709, 9482120, 9482121, 9482122, 9482124, 9482125, 9482126, 9482127, 9486300, 9486301, 9486302, 9506575, 9506576, 9506577, 9506578, 9506579, 9506581, 9508748, 9508749, 9508750, 9512178, 9515062, 9515063, 9515132, 9517941, 9517965, 9517966, 9517968, 9517969, 9517970, 9517974, 9561011, 9566155, 9566176, 9566177, 9569135, 9569136, 9572239, 9572240, 9575340, 9581850, 9581851, 9581852, 9584258, 9584260, 9587392, 9587393, 9587394, 9587395, 9587424, 9587425, 9587426, 9587427, 9587428, 9587429, 9587430, 9587431, 9592483, 9594200, 9594220, 9594221, 9598730, 9602931, 9602932, 9605706, 9605707, 9605708, 9605709, 9605710, 9605711, 9609111, 9609112, 9620381, 9620391, 9620392, 9620393, 9620394, 9625904, 9629879, 9633299, 9633302, 9633303, 9633304, 9633305, 9633306, 9633307, 9633308, 9633309, 9633335, 9636344, 9636345, 9636346, 9636347, 9640567, 9640568, 9640569, 9640570, 9640571, 9647075, 9647101, 9647102, 9647103, 9647104, 9647105, 9647106, 9647107, 9647108, 9650089, 9650090, 9653860, 9653884, 9653885, 9653886, 9653887, 9653888, 9653889, 9653890, 9653891, 9276034X, 9370230X 9272844, 9272846, 9272847, 9272848, 9272849, 9272850, 9272851, 9272852, 9276035, 9279129, 9279130, 9283230, 9370248, 9370249, 9370250, 9386595, 9386655, 9394038, 9396612, 9396613, 9396614, 9396615, 9396616, 9426564, 9426565, 9426567, 9426568, 9426571, 9466883, 9466884, 9470223, 9470237, 9478710, 9478711, 9478712, 9482111, 9482112, 9482115, 9482129, 9482130, 9482131, 9486303, 9506585, 9512179, 9512180, 9512181, 9512182, 9512183, 9512184, 9512185, 9512186, 9515064, 9517977, 9517978, 9517979, 9517981, 9517984, 9517985, 9534268, 9534269, 9534270, 9534316, 9534317, 9534318, 9534319, 9534320, 9534321, 9534322, 9534323, 9534324, 9534325, 9534326, 9569137, 9572241, 9572242, 9572243, 9572244, 9572245, 9572246, 9572247, 9572248, 9575341, 9575342, 9581853, 9605687, 9605688, 9633257, 9633258, 9642956, 9647036, 9660191, 9506585X 9276036, 9276037, 9276038, 9276039, 9283232, 9283233, 9283234, 9283235, 9391306, 9396541, 9396620, 9426572, 9464251, 9466885, 9466886, 9466887, 9474579, 9478713, 9478714, 9482132, 9512187, 9515065, 9517988, 9517989, 9517990, 9517991, 9529012, 9529014, 9534329, 9561012, 9566178, 9572252, 9572253, 9572254, 9575343, 9575344, 9584261, 9594223, 9594224, 9594225, 9594226, 9605691, 9605712, 9605713, 9605714, 9605715, 9609113, 9620395, 9620396, 9623938, 9625895, 9625905, 9636348, 9636349, 9636350, 9640572, 9640573, 9640574, 9640575, 9647076, 9647109, 9647110, 9647111, 9647112, 9647113, 9650091, 9650092, 9650093, 9653861, 9653892, 9660211, 9664015 9400629, 9400630, 9486304, 9515066, 9517943, 9517994, 9517995, 9517996, 9534334, 9534335, 9534336, 9561013, 9572255, 9584262, 9584263, 9594201, 9594227, 9602901, 9605716, 9636300, 9636351, 9636352, 9647043, 9647077, 9647078, 9647114, 9647115, 9660201, 9660212, 9660213 9276040, 9400632, 9426580, 9517944, 9517998, 9557566, 9560987, 9566179, 9594229, 9605717, 9609114, 9611322, 9617438, 9620397, 9642971, 9653893, 9656987, 9656988, 9656993, 9656996 9276041, 9283222, 9283237, 9283238, 9365246, 9386600, 9386601, 9426581, 9426582, 9466889, 9478715, 9478716, 9529018, 9557567, 9560988, 9561014, 9572261, 9575346, 9594230, 9594231, 9609115, 9611323, 9625906, 9625907, 9633310, 9636353, 9647116, 9647117, 9653862, 9653863, 9653894 9276021, 9279005, 9279006, 9365247, 9365248, 9365249, 9365250, 9365251, 9365252, 9386602, 9386657, 9391309, 9391310, 9396543, 9396544, 9400672, 9426584, 9426585, 9464257, 9470225, 9478717, 9482133, 9482134, 9515067, 9518002, 9518003, 9518004, 9522380, 9529019, 9529020, 9529021, 9534274, 9566180, 9566181, 9569080, 9572262, 9572263, 9572264, 9572265, 9572266, 9572267, 9572268, 9581857, 9581858, 9581859, 9581860, 9581861, 9581862, 9594233, 9594234, 9594235, 9594236, 9594237, 9594238, 9594239, 9594240, 9609116, 9609117, 9609118, 9609119, 9609120, 9609121, 9609122, 9611324, 9611325, 9611326, 9620398, 9620399, 9620400, 9620401, 9620402, 9620403, 9620404, 9623939, 9633311, 9636354, 9636355, 9636356, 9636357, 9640576, 9640577, 9647079, 9647118, 9647119, 9647120, 9647121, 9650094, 9650095, 9650096, 9656989, 9660214, 9660215, 9664020 9283224, 9283239, 9283240, 9365253, 9391314, 9396546, 9464258, 9474583, 9478691, 9478718, 9478719, 9478720, 9478721, 9486305, 9486306, 9512191, 9512192, 9515068, 9515069, 9515070, 9515071, 9517945, 9518013, 9518015, 9522381, 9522382, 9522383, 9522384, 9529022, 9529023, 9529024, 9529025, 9529026, 9529027, 9555457, 9555458, 9555459, 9555460, 9555461, 9566184, 9572271, 9572272, 9572273, 9572274, 9572275, 9572276, 9575347, 9578358, 9581846, 9581863, 9581864, 9581865, 9581866, 9581867, 9581868, 9594242, 9594243, 9594244, 9594245, 9594246, 9609100, 9609123, 9609124, 9620405, 9620406, 9620407, 9620408, 9620409, 9620410, 9629880, 9633312, 9633313, 9633314, 9633315, 9633316, 9633317, 9636284, 9636358, 9640522, 9640578, 9640579, 9640580, 9647080, 9647081, 9650097, 9650098, 9650099, 9650100, 9650101, 9650108, 9653864, 9653899, 9653900, 9653901, 9663993, 9663994, 9663995, 9664021, 9664022, 9664023, 9664024, 9664025 9386604, 9386605, 9478722, 9478723, 9482135, 9486308, 9512193, 9515073, 9522385, 9522386, 9525174, 9529028, 9561015, 9561016, 9566186, 9572281, 9575348, 9578359, 9581869, 9581870, 9584267, 9594202, 9594249, 9594250, 9609101, 9609125, 9609126, 9609127, 9611327, 9620411, 9620412, 9386604X, 9478723X 9478724, 9478725, 9522388, 9557568, 9560989, 9561017, 9566187, 9569086, 9572283, 9572284, 9575349, 9578360, 9598725, 9602900, 9602902, 9602903, 9611328, 9611329, 9611330, 9620413, 9647082, 9647083, 9650056, 9650102, 9650103, 9656968, 9656969, 9671109, 9671112 9412948, 9466894, 9522390, 9560991, 9566188, 9569087, 9611331, 9620414, 9633318, 9650104, 9650105, 9650109, 9656970, 9656971, 9671110, 9671111 9276043, 9276044, 9515075, 9522391, 9560992, 9561020, 9575350, 9611315, 9611332, 9611333, 9620415, 9625908, 9625909, 9636359, 9636360, 9650110, 9656972 9276023, 9276045, 9276298, 9276299, 9276300, 9276301, 9361560, 9386610, 9386611, 9400693, 9464262, 9464263, 9592449, 9592451, 9592452, 9592453, 9592454, 9592455, 9592456, 9592457, 9592458, 9592459, 9592460, 9592461, 9598718, 9598719, 9598720, 9598721, 9598722, 9605683, 9605684, 9605685, 9609072, 9609073, 9609074, 9609075, 9623875, 9623876, 9623877, 9623878, 9625846, 9633256, 9640512, 9671029, 9671030, 9671032, 9671033, 9386610X, 9386613 9276302, 9276303, 9276304, 9276305, 9276306, 9276307, 9365254, 9370212, 9386614, 9386615, 9386616, 9386642, 9386643, 9386645, 9415644, 9461576, 9478729, 9478730, 9486310, 9486311, 9515076, 9515078, 9515079, 9515080, 9522394, 9522395, 9522396, 9522397, 9522398, 9525176, 9525177, 9529029, 9529031, 9529032, 9529033, 9529044, 9560994, 9560995, 9561022, 9566189, 9566191, 9566192, 9566194, 9575352, 9575353, 9575354, 9575355, 9575356, 9575357, 9584268, 9598734, 9598735, 9611334, 9611335, 9611336, 9611337, 9611338, 9620416, 9623927, 9623941, 9623942, 9623943, 9623944, 9623945, 9623946, 9625910, 9629881, 9633319, 9633320, 9633321, 9633322, 9633323, 9633324, 9633325, 9636361, 9636362, 9642972, 9642973, 9642974, 9653865, 9656973, 9656974, 9656975, 9656976, 9656977, 9656991, 9664000 9376505, 9376506, 9376507, 9376580, 9376581, 9383408, 9383409, 9461581, 9522401, 9560996, 9566198, 9575358, 9575359, 9575360, 9575361, 9581871, 9581872, 9592484, 9594203, 9611340, 9611342, 9611344, 9611346, 9633326, 9633327 9376508, 9376509, 9376582, 9376583, 9560997, 9566199, 9609087, 9609102, 9609103, 9611347, 9611348, 9620380, 9623928, 9623947, 9623948, 9636363, 9636364, 9647084, 9650057, 9650058, 9653829, 9653866, 9653867, 9660202, 9664002, 9664003, 9664029, 9664030 9560998, 9566200, 9609104, 9611349, 9611350, 9623949, 9636365, 9650059, 9653868, 9664004, 9664031, 9664782 9555469, 9566201, 9569088, 9575365, 9575366, 9581873, 9623950, 9629882, 9633328, 9636366, 9642975, 9647085, 9650042, 9650046, 9650047, 9650051, 9650060, 9653869, 9653870, 9663988, 9664005, 9664032, 9664033 9365288, 9365289, 9376585, 9376586, 9376587, 9466898, 9560999, 9566206, 9575371, 9578361, 9581874, 9581875, 9598738, 9611351, 9611352, 9611353, 9611354, 9611355, 9623929, 9623951, 9623952, 9623953, 9623954, 9636367, 9640581, 9640582, 9642976, 9650106, 9650107, 9650111, 9660203, 9664006, 9664007, 9664008, 9664009, 9664034, 9664035 9365290, 9365291, 9376589, 9376590, 9380004, 9383412, 9386651, 9566153, 9566158, 9566210, 9575374, 9575376, 9575377, 9581877, 9584270, 9605692, 9605693, 9611357, 9611358, 9611359, 9611360, 9623955, 9623956, 9623957, 9623958, 9625911, 9625912, 9633329, 9633330, 9633331, 9633332, 9636368, 9636369, 9640583, 9650112, 9653871, 9653872, 9653873, 9664010, 9664011, 9664780, 9664781

510(k) numbers

not on file

PMA numbers

not on file

Product code

MIH

Firm FEI

1820334

Firm city

Bloomington

Firm state

IN

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