Inspire Sleep Apnea Implant recallZ-2516-2026 · Inspire Medical Systems Inc. · initiated May 11, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Inspire Medical Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
Firm 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.
Recall details
- Recall number
- Z-2516-2026
- Status
- Open, Classified
- Initiated by the company
- May 11, 2026
- Posted by the FDA
- Jun 18, 2026
- Recalling firm
- Inspire Medical Systems Inc.
- Quantity
- 10 impacted units
- Product code
- MNQ
- FDA submissions
- P130008
- Distribution
- Worldwide distribution - US Nationwide and the country of Hong Kong.
Product description
Brand 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 (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Inspire 900-013-001Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea2 recalls359 reports
- Inspire 900-013-003Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea1 recall0 reports
Product lines
Other devices under the same FDA submission
22 devices cleared under P130008 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Inspire 900-007-014Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea3 deaths1,012 reports
- Inspire 900-007-008Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea1 death248 reports
- Inspire 900-009-002Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea138 reports
- Inspire 900-001-009Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea125 reports
- Inspire 900-001-011Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea56 reports
- Inspire 900-014-005Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea1 recall0 reports
- Inspire 900-007-003Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea46 reports
- Inspire 900-003-015Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea45 reports
- Inspire 900-009-003Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea43 reports
- Inspire 900-001-008Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea26 reports
- Inspire 900-002-005Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea17 reports
- Inspire 900-001-005Inspire Medical Systems, Inc. · Stimulator, Hypoglossal Nerve, Implanted, Apnea13 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98990).
- Z-2515-2026 · Open, ClassifiedBrand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respirato…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page