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U.S. Department of Health and Human Services

Class 2 Device Recall Inspire Model 4340 Respiratory Sensing Lead

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 Class 2 Device Recall Inspire Model 4340 Respiratory Sensing Leadsee related information
Date Initiated by FirmJuly 31, 2024
Date PostedOctober 09, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0040-2025
Recall Event ID 95230
Product Classification Stimulator, hypoglossal nerve, implanted, apnea - Product Code MNQ
ProductInspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Code Information Model 4340. UDI-DI: 10855728005946. Part Number: 900-014-00. Serial Numbers: D59544, D59550, D59543, D59541, D59542, D59528, D59526, D59534, D59521, D59477, D59519, D59515, D59516, D59489, D59514, D59512, D59510, D59509, D59547, D59549, D59505, D59506, D59504, D59503, D59502, D59529, D59497, D59494, D59490, D59485, D59486, D56077, D56072, D56064, D56060, D56059, D56055, D56038, D56082, D56035, D56044, D56031, D56032, D56033, D56034, D56040, D56046, D56030, D56036, D56053, D56054, D56058, D55284, D48681, D48668, D48661, D48655, D48650, D48410, D46477, D46478, D43687, D43688, D43700, D48014, D48007, D47994, D47991, D47983, D47964, D47963, D47958, D47940, D45763, D47939, D45768, D47913, D47228, D47903, D47896, D47897, D47909, D47910, D47951, D45706, D45721, D45724, D47877, D47872, D47879, D47880, D47691, D47670, D47654, D47243, D47240, D47220, D47187, D47181, D47176, D47177, D47191, D47192, D47175, D47169, D47163, D47164, D47142, D47131, D47926, D47102, D47013, D47006, D46990, D46966, D46955, D46854, D46855, D46847, D46846, D46835, D46804, D46797, D46784, D47202, D46699, D46700, D46664, D46566, D46567, D46561, D46535, D46532, D46527, D46528, D46529, D46525, D46526, D46463, D46451, D45962, D45949, D45947, D45777, D45773, D45745, D45708, D44687, D44685, D44677, D44675, D26997.
FEI Number 3007666314
Recalling Firm/
Manufacturer		 Inspire Medical Systems Inc.
5500 Wayzata Blvd Ste 1600
Golden Valley MN 55416-1237
For Additional Information ContactAndrea Rasmussen
763-205-7974
Manufacturer Reason
for Recall		Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
FDA Determined
Cause 2		Process control
ActionInspire notified consignees on 07/31/2024, via emailed letter. Consignees were instructed to confirm the serial number on the lead is the serial number used to register the patient and to contact your Inspire representative if any labeling inconsistency is identified for complaint reporting.
Quantity in Commerce152 units
DistributionWorldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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