Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
FDA device recall Z-0041-2025 · posted 2024-10-09 · Open, Classified
Recall details
- Recalling firm
- Inspire Medical Systems Inc.
- 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.
- Action taken
- Inspire 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- MNQ
- Quantity affected
- 457 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.
- Date initiated
- 2024-07-31
- Date posted
- 2024-10-09
- Location
- Golden Valley, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.