Boston Scientific Corporation: MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Recall number

Z-1798-2020

Recalling firm

Boston Scientific Corporation

Product

MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Status

Terminated

Initiated

2020-03-30

Posted

not on file

Terminated

2023-04-05

Reason

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.

Root cause

Use error

Action

An Urgent Medical Device Product Advisory - Immediate Action Required dated 3/30/20 was sent to customers. Existing MoXy" laser fiber Direction for Use to be Reinforced 1- Ensure the distance from the fiber to the tissue is approximately 2mm (1 to 3 mm). Reference: Table 2. Troubleshooting and Procedural Considerations in product DFU. 2- Do not bury the tip of the fiber into the tissue. Reduced irrigation flow may result in damage to the fiber. Reference: Caution in page 3 of product DFU. 3- Failure to position the saline solution at least 106cm or not opening the flow valve will decrease the amount of fluid across the fiber end. Decreased fluid flow may limit the lasing time of the fiber. Reference: Caution in page 3 of product DFU. Section 8.3 of the MoXyTM Laser Fiber DFU has been updated to recommend an increased irrigation flow to increase the liquid cooling effect. The additions to the current DFU are highlighted in blue: 8.3 Performing the Procedure 1. Ensure user, patient, and personnel in the room are wearing appropriate protective eyewear before using the laser. WARNING: Do not press the footswitch without having the appropriate protective eyewear. Pressing the footswitch may activate the laser beam. Activation of the laser beam when not wearing protective eyewear may result in eye injury to the user, personnel in the room, or the patient. 2. Connect the tubing from the sterile saline for irrigation solution to the fiber luer lock connector. Position the saline solution at least 106 cm higher than the level of the endoscope/cystoscope. Increased irrigation flow by means of a saline pressure bag (set to 250 mmHg 300 mmHg) will further increase liquid cooling effect and may reduce fiber tip damage. Please complete and return the acknowledgement form to indicate receipt of this letter. Boston Scientific Quality Systems 763-494-1133 BSCFieldActionCenter@bsci.com

Quantity

146,633

Distribution

Worldwide distribution - US Nationwide and Global distribution.

Lot, serial or model codes

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, 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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

510(k) numbers

["K120870"]

PMA numbers

not on file

Product code

GEX

Firm FEI

3005099803

Firm city

Marlborough

Firm state

MA

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

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