Recall Z-0040-2025— Inspire Medical Systems Inc.
Class II · Ongoing
Class II FDA medical device recall by Inspire Medical Systems Inc., initiated 2024-07-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.. Reason: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box..
- Recalling firm
- Inspire Medical Systems Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-31
- Firm location
- Golden Valley, MN, United States
Product description
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.