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MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgic...

FDA Device Recall #Z-1798-2020 — Class II — March 30, 2020

Recall Summary

Recall Number Z-1798-2020
Classification Class II — Moderate risk
Date Initiated March 30, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Boston Scientific Corporation
Location Marlborough, MA
Product Type Devices
Quantity 146,633

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide distribution - US Nationwide and Global distribution.

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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