Recall of Device Recall GlideScope Video Laryngoscope (GVL)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Verathon, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Laryngoscope, rigid - Product Code CCW
  • Reason
    Certain models and serial numbers of glidescope gvl and avl laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. the potential for blade separation may not be readily visible during routine inspection before or after intubation.
  • Action
    The Urgent Medical Device Recall letter, dated November 30, 2015, had an error on the dates of manufacture for the AVL devices. Once Verathon discovered the incorrect information, the notification letter was revised and it was sent on December 7, 2015 to any customers that received the previous letter between 11/30/15 and 12/2/15. **************************************************************************************** Verathon sent an Urgent Medical Device Recall letter dated November 30, 2015, to all affected consignees. Verathon will, at no cost to you, test your GlideScope GVL and/or AVL blades that fall within the serial number ranges identified to determine whether the blades exhibit the defect that may result in separation of the blade. For all blades that we determine to exhibit this defect, Verathon will replace the blade, free of charge, with a blade of the same model and size. If the blade passes the testing without any evidence of the defect, we will return it to you in its current condition. Please note that this testing will not return blades to their original, factory condition. Verathon will provide you with a loaner blade for each blade in your possession that is subject to this recall, so you will not experience any interruption in use of your GlideScope system. To comply with this recall notice for the affected models and serial numbers of GlideScope GVL and A VL blades, please take the following actions: " Fill out the attached Recall Response Form and return it to Verathon by fax, (425) 883-2896, or email, . Please return the form even if you do not have any blades subject to the recall. " Contact Customer Care to arrange for delivery of a loaner blade and return of your recalled blade. Customer Care will issue you an "RMA" number and arrange for shipment of a loaner blade. Do not send us your current blade(s) until you receive the loaner blade(s). Should you have any questions about th


  • Model / Serial
    ***ADDITIONAL 72 SERIAL NUMBERS IN US AND INTERNATIONAL AS OF 12/31/15 ***  LG151991, LG152083, LG152084, LG152180, LG152181, LG152183, LG152184, LG152185, LG152186, LG152187, LG152188, LG152189, LG152191, LG152192, LG152193, LG152194, LG152195, LG152196, LG152197, LG152198, LG152199, LG152201, LG152202, LG152203, LG152204, LG152205, LG152206, LG152207, LG152208, LG152209, LG152210, LG152216, LG152217, LG152218, LG152219, LG152220, LG152221, LG152222, LG152223, LG152224, LG152225, LG152226, MD151720, MD151835, MD151879, MD151880, MD151881, MD151882, MD151883, MD151885, MD151886, MD151887, MD151888, MD151891, MD151895, MD151896, MD151897, MD151898, MD151900, MD151901, MD151902, MD151903, MD151904, MD151921, MD151923, MD151924, MD151925, MD151926, MD151927, MD151928, XL151554, and XL151569.     ****SERIAL NUMBERS OF UNITS IN THE US***************************************** LG151858, LG151859, LG151860, LG151861, LG151862, LG151863, LG151866, LG151868, LG151869, LG151870, LG151872, LG151873, LG151874, LG151875, LG151876, LG151877, LG151878, LG151880, LG151881, LG151882, LG151883, LG151884, LG151885, LG151890, LG151891, LG151892, LG151893, LG151894, LG151895, LG151896, LG151898, LG151899, LG151900, LG151901, LG151903, LG151904, LG151906, LG151907, LG151908, LG151909, LG151917, LG151918, LG151919, LG151920, LG151921, LG151922, LG151923, LG151924, LG151925, LG151926, LG151927, LG151928, LG151930, LG151931, LG151932, LG151933, LG151934, LG151935, LG151936, LG151937, LG151938, LG151939, LG151940, LG151941, LG151942, LG151943, LG151944, LG151945, LG151946, LG151947, LG151948, LG151949, LG151952, LG151953, LG151954, LG151955, LG151957, LG151959, LG151961, LG151963, LG151964, LG151965, LG151967, LG151969, LG151972, LG151977, LG151978, LG151979, LG151981, LG151984, LG151985, LG151986, LG151987, LG151988, LG151989, LG151990, LG151993, LG151994, LG151996, LG151997, LG151998, LG152000, LG152001, LG152002, LG152003, LG152004, LG152005, LG152006, LG152007, LG152008, LG152009, LG152010, LG152011, LG152012, LG152013, LG152014, LG152015, LG152016, LG152017, LG152018, LG152019, LG152020, LG152021, LG152022, LG152023, LG152024, LG152025, LG152026, LG152027, LG152028, LG152029, LG152030, LG152032, LG152033, LG152034, LG152036, LG152037, LG152038, LG152039, LG152044, LG152045, LG152046, LG152048, LG152049, LG152050, LG152051, LG152052, LG152053, LG152054, LG152058, LG152059, LG152060, LG152061, LG152062, LG152063, LG152065, LG152066, LG152067, LG152069, LG152071, LG152072, LG152073, LG152074, LG152076, LG152079, LG152081, LG152082, LG152085, LG152086, LG152087, LG152088, LG152089, LG152090, LG152092, LG152093, LG152094, LG152095, LG152096, LG152097, LG152098, LG152099, LG152100, LG152101, LG152102, LG152103, LG152104, LG152105, LG152106, LG152107, LG152113, LG152114, LG152115, LG152116, LG152117, LG152118, LG152119, LG152120, LG152121, LG152122, LG152124, LG152126, LG152132, LG152133, LG152134, LG152135, LG152140, LG152141, LG152142, LG152143, LG152144, LG152145, LG152146, LG152147, LG152148, LG152150, LG152152, LG152153, LG152154, LG152155, LG152156, LG152158, LG152159, LG152160, LG152161, LG152162, LG152163, LG152164, LG152170, LG152171, LG152172, LG152173, LG152178, LG152179, MD151705, MD151706, MD151707, MD151708, MD151709, MD151710, MD151711, MD151712, MD151713, MD151717, MD151718, MD151719, MD151727, MD151728, MD151729, MD151730, MD151731, MD151733, MD151744, MD151745, MD151746, MD151748, MD151749, MD151750, MD151752, MD151753, MD151754, MD151756, MD151757, MD151758, MD151760, MD151761, MD151762, MD151766, MD151767, MD151768, MD151769, MD151770, MD151771, MD151772, MD151773, MD151774, MD151775, MD151776, MD151779, MD151780, MD151781, MD151782, MD151783, MD151785, MD151786, MD151787, MD151788, MD151789, MD151792, MD151793, MD151794, MD151795, MD151796, MD151797, MD151798, MD151799, MD151800, MD151801, MD151802, MD151803, MD151804, MD151805, MD151806, MD151807, MD151808, MD151812, MD151817, MD151818, MD151819, MD151822, MD151823, MD151824.MD151825, MD151826, MD151827, MD151828, MD151829, MD151830, MD151831, MD151832, MD151833, MD151834, MD151837, MD151839, MD151840, MD151841, MD151842, MD151843, MD151844, MD151845, MD151846, MD151847, MD151848, MD151850, MD151851, MD151852, MD151853, MD151854, MD151855, MD151856, MD151857, MD151858, MD151860, MD151861, MD151862, MD151863, MD151864, MD151865, MD151866, MD151868, MD151869, MD151870, MD151871, MD151872, MD151875, MD151876, MD151877, MD151878, MD151931, MD151932, XL151543, XL151545, XL151546, XL151547, XL151548, XL151549, XL151551, XL151552, XL151556, XL151557, XL151558, XL151559, XL151560, XL151562, XL151563, XL151564, XL151566, XL151567, XL151568, XL151570, and XL151572.   ****SERIAL NUMBERS OF UNITS OUTSIDE THE US*******************  LG151886, LG151887, LG151888, LG151905, LG151910, LG151911, LG151912, LG151913, LG151914, LG151915, LG151916, LG151950, LG151951, LG151958, LG151960, LG151962, LG151966, LG151973, LG151974, LG151975, LG151976, LG151980, LG151982, LG151983, LG151992, LG151995, LG151999, LG152031, LG152035, LG152040, LG152041, LG152042, LG152043, LG152047, LG152055, LG152056, LG152057, LG152064, LG152075, LG152077, LG152078, LG152080, LG152091, LG152108, LG152109, LG152110, LG152111, LG152112, LG152123, LG152125, LG152127, LG152128, LG152129, LG152130, LG152131, LG152136, LG152137, LG152138, LG152139, LG152149, LG152151, LG152157, LG152165, LG152167, LG152168, LG152169, LG152174, LG152175, LG152176, LG152177, LG152211, LG152212, LG152213, LG152214, LG152215, LG152227, LG152228, LG152229, LG152231, LG152232, MD151685, MD151686, MD151687, MD151688, MD151689, MD151690, MD151691, MD151692, MD151693, MD151694, MD151695, MD151696, MD151697, MD151698, MD151699, MD151700, MD151701, MD151702, MD151703, MD151704, MD151714, MD151715, MD151716, MD151721, MD151722, MD151723, MD151724, MD151725, MD151732, MD151734, MD151735, MD151736, MD151737, MD151738, MD151740, MD151741, MD151742, MD151755, MD151759, MD151763, MD151764, MD151765, MD151777, MD151778, MD151784, MD151790, MD151791, MD151809, MD151810, MD151811, MD151813, MD151814, MD151815, MD151816, MD151820, MD151821, MD151859, MD151873, MD151874, MD151905, MD151906, MD151907, MD151908, MD151909, MD151910, MD151911, MD151912, MD151914, MD151915, MD151916, MD151917, MD151918, MD151919, MD151920, MD151929, MD151930, XL151544, XL151550, XL151561, and XL151571.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - US (nationwide including Puerto Rico) and Internationally to Bahrain, Belgium, Bermuda, Brunei Darussalam, Bulgaria, Canada, China , Czech Republic, Denmark, France, Georgia, Germany, Greece, India , Indonesia, Iran , Israel, Italy , Japan, Kuwait, Lebanon, Malaysia, Morocco, Palestinian Territories, Panama, Peru, Philippines, Republic of Serbia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, and U.A.E.
  • Product Description
    GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. || The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. || GVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor.
  • Manufacturer


  • Manufacturer Address
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Manufacturer Parent Company (2017)
  • Source