Inspire Medical Systems Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0040-2025 | Class II | Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) | July 31, 2024 |
| Z-0041-2025 | Class II | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system. | July 31, 2024 |
| Z-2159-2024 | Class I | Inspire Model 3028, IV Implantable Pulse Generator | May 16, 2024 |
| Z-2969-2018 | Class II | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #9 | June 12, 2018 |