Boston Scientific Corporation recalls MoXy Laser Fiber, Material Number 0010-2400 - Product Usage:

Hazard / Issue

To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Lot Numbers: 21857621,21857622,2 1885 133, 21885134, 21911808, 21918152,21933082,21955208,21966592,21972810, 22012232,22012233,22045291,22045292,22075867, 22075868, 22102605,22133874,22133875,22164395, 22192454,22214668,22214669,22240533,22240534, 22277294,22277295,22316091 , 22316094,22332788, 22332789,22367863, 22367864, 22399660, 22399661, 22430500,22460693,22491910,22523850,22523851, 22555544,22555545,22582191,22614412,226 1441 3, 22648469,22648471,22676727,22676728,22699074, 22714526,22714527,22748233,22779616, 2281 1499, 2284484 1, 22870995, 22870996,22903769,22903770, 22940569, 22973787,23006403, 23006404, 23025859, 23043565 ,23043566, 23046805,23069530, 23075003, 23079824,23079825, 23091108,23122367, 23 126934, 23 140183, 23 167998,23 199218,23199219,23201285, 23208313,23222999,23255764,23279578,23279669, 23279671, 23306204, 2331 1423,23339555,23348091, 23351254, 23359328,23360252,23371259,23371620, 23381026,23396932,23416792,23421082,23421088, 23421089,23421090,23444025,23453065,23456091, 23456092,23459552,23475445,23487672,23487673, 23502386,23502387,23527139,23527680,23564080, 23584254,23584255,23584256,23584257,23584258, 23584259,23584520,23584521 , 23584522, 23584523, 23594603,23601171,23624442, 23637809,23637810, 23637811,236378 12,23637813, 23637814, 23637816, 23637817,23637818,23637819, 23654470,23654471, 23678280,2367828 1,23678282, 23678283,23678284, 23678285, 23678286, 23678287,23678288,23678289, 23681574, 23728199,23728580,23728581,23728582, 23728583,23728584, 23728585,23728586, 23728587, 23728588,2373 1972,23731973,23743490,23743491, 23743492,23743493,23743494,23743495,23743496, 23743497,23743498,23743499,23744140, 23760138, 23760139,23797692,23833016,23833017,23833018, 23833019,23833460,23833461 , 23833462,23833463, 23833464,23833465,23833466, 23842248,23866396, 23869547, 23880108, 23880 110, 238801 11 , 23880112, 238801 13, 23880114,238801 15,23880116,2388011 7, 238801 18,23880 119, 23880340, 23891911,23891912, 23891913,23891914, 23891915, 23891916, 2389191 7, 2389191 8,23891919,23891980, 23891981, 23891982, 23891983,23904090, 23904091,23938085,23938086, 23938087,23938088, 23938089,23938090,23938091, 23938092,23938093, 23938094,23938095,23948722, 23948723,23969006,23969007,23969008, 23969009, 23969010,23969011, 23984808, 23988327,23988328, 23988329,23988330,23988331,24005956,24005957, 24005958, 24005959,24006260, 24016594,24016595, 240 16596,24020050,24020053 , 24020055,24020056, 24020057,24020058,24020200,24020201,24020202, 24020203,24061327,24061328,24061329,24061330, 2406 133 1,24061332,24061333,24080708, 24080709, 240807 12,24080713, 24080714,24080715,24119349, 24120925, 24120926, 24120927,24120928, 24120929, 24120930,24120931,24 120932,24120933, 24144105, 24144106,24144107,24144109,24144112,24144113, 24144114,24144116,24144120, 24144122, 24164686, 24164688,24164689,24 164690,2416469 1, 24164697, 24164698,241 64699,24164780,2416478 1, 24256724, 24256725, 24256726,24256727, 24263835, 24263836, 24263837, 24263838, 24263839,24264081, 24284565, 24284566, 24284673,2429251 1,242925 12,242925 13, 24292514, 24292515, 24292516, 24321100,24321101, 24321 102,24321 103, 2433850 1,24338502,24338503, 24338504,24338505,24344619, 24344980,24344981, 24344982,24344983,24344984,24370426, 24370427, 24370428,24370429, 24370430,24370431 , 24370432, 24370433,24370434,24370435,24370436,24370437, 24385280, 24385281,24385282, 24385283,24385284, 24385285,24385286, 24385287,24385288,24385289, 24385290,24385291,24385292,24385293,24385294, 24385295, 24416902,24416903,24416904,24416905, 24416906,24416907, 24416908, 24416909,244169 10, 244 169 11,24416912, 24416913, 24416914,244169 15, 244 16916,2441691 7, 24462677,24462678, 24462679, 24462880,24462881,24462882, 24462883, 24462884, 24462885,24462886, 24502701,24502702,24502703, 24502704, 24502705 , 24502706,24502707,24502708, 24502709, 24502710, 24540583, 24540585, 24540586, 24540587, 24540589,24559282,24559283,24559284, 24559286, 24559287, 24559288, 24559290, 24559292, 24559294,24559296,24595095,24595096,24595097, 24595098,24603242,24603243, 24603244,24603245, 24603246, 24603247, 24603248,24603249,24603250, 2460325 1,24622555, 24622556,24628310, 246283 11, 246283 12,24655514,246555 15,24657762, 24657763, 24657764,24657765, 24657767,24657770,24657772, 24657774,24657777, 24657778, 24657880, 24657883, 24704505, 24704506,24704507,24704508,24704509, 24704510, 247045 11 ,24704512,247045 13,24704514, 24704515,24704516,24704517,24704518,24722976, 24722977,24722978,24722979,24723160, 24723 161 , 24723162, 24723163,24723164,24723165, 24723 166, 24723167, 24723168,24760491,24760492,24765852, 24765853, 24765854, 24765855,24765856, 24765857, 24765858,24765859,24766480,24766481,24766482, 24766483, 24782719, 24783620,24783621, 24783622, 24783623,24806035,24806036, 24806037,24806038, 24806039,24806780,24806781 , 24806782, 24806783, 24806784,24806785, 24806786,24806787, 24823940, 24848075, 24848076, 24848077, 24848078,24848079, 24860957, 24860958, 24860959,24861220,24861221, 24883176, 24883177,24883178,24883179,24902874, 24909210, 24909211,24970260,24970261,24972055, 24972056, 24974380, 24974381, 24974382, 24974383, 2498841 l, 24988412, 24988413,24988414,24988415, 24995871,24995872,25017985,25017986,25027902, 25027903,25027904,25027905,25027906,25027907, 250677 18,25067719,25067800,25067801,25067802, 25067803, 25067804, 251 12908,25112910,25112911, 25112912,25112913,25112914,25112915,25112916, 25142926, 25 142927, 25142928,25142929,25142930, 25142931,25 142932,25142933