Inspire stimulation leads labeled with Use By dates beyond shelf life
Inspire Stimulation Leads, model 4063, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 10 units affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where an overstated expiry date could allow implantation of degraded material, with a stated risk of revision surgery and no injuries reported.
Plain-English summary
The Inspire Stimulation Lead, model/catalog number 4063, from Inspire Medical Systems, Inc., is being recalled. The lead is designed to deliver stimulation to the hypoglossal nerve. The action covers 10 impacted units, UDI-DI 10855728005793.
The products are labeled with an incorrect Use By Date, extending beyond the validated three-year shelf life from the date of manufacture. According to the manufacturer, material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States and to Hong Kong. The leads are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI-DI and part numbers in the recall notice, quarantine it, and follow the instructions issued by Inspire Medical Systems.
The recalled product
- Product
- 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.
- Manufacturer
- Inspire Medical Systems Inc.
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Inspire Medical Systems Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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