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U.S. Department of Health and Human Services

Class 2 Device Recall Inspire Medical Systems, Inc.

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 Class 2 Device Recall Inspire Medical Systems, Inc.see related information
Date Initiated by FirmMay 11, 2026
Date PostedJune 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2516-2026
Recall Event ID 98990
PMA NumberP130008 
Product Classification Stimulator, hypoglossal nerve, implanted, apnea - Product Code MNQ
ProductBrand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A
Code Information Lot Code: Model 4063 (USA only lead); UDI-DI [4063] 10855728005793; Inspire part number [4063] 900-013-001; serial numbers D53393, D61104 Model 4063 (Global lead); UDI-DI [4063] 10810098650295, Inspire part number [4063] 900-013-003; serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959
FEI Number 3007666314
Recalling Firm/
Manufacturer		 Inspire Medical Systems Inc.
5500 Wayzata Blvd Ste 1600
Golden Valley MN 55416-1237
For Additional Information Contact
763-205-7974
Manufacturer Reason
for Recall		Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
FDA Determined
Cause 2		Process control
ActionFirm began notifying consignees on May 11, 2026. Letters were titled "URGENT Medical Device Correction." The firm requests consignees' assistance in removing affected product from clinical inventory and returning them to Inspire.
Quantity in Commerce10 impacted units
DistributionWorldwide distribution - US Nationwide and the country of Hong Kong.
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.
PMA DatabasePMAs with Product Code = MNQ
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