GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 057...
FDA Device Recall #Z-0420-2016 — Class II — November 30, 2015
Recall Summary
| Recall Number | Z-0420-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 30, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Verathon, Inc. |
| Location | Bothell, WA |
| Product Type | Devices |
| Quantity | total 612 units (394 units in the US and 218 units outside the US) |
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.
Reason for Recall
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.
Distribution Pattern
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.
Lot / Code Information
***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.
Other Recalls from Verathon, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2022-2024 | Class II | Brand Name: GlideScope Core 15-inch FHD Model/... | Apr 29, 2024 |
| Z-2021-2024 | Class II | Brand Name: GlideScope Core 15-inch Monitor Mo... | Apr 29, 2024 |
| Z-2172-2021 | Class III | GlideScope Go Monitors | Jul 1, 2021 |
| Z-0531-2021 | Class II | BladderScan Prime Plus Probe REF 0570-0395 - Pr... | Sep 29, 2020 |
| Z-2476-2020 | Class I | GlideScope Core OneTouch Smart Cable, REF: 0800... | Jun 5, 2020 |
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.