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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1798-2020
Related Recalls
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Boston Scientific
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia