Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Reported: October 16, 2024 Initiated: July 31, 2024 #Z-0040-2025
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.
Details
- Recalling Firm
- Inspire Medical Systems Inc.
- Units Affected
- 152 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.
- Location
- Golden Valley, MN
Frequently Asked Questions
What product was recalled? ▼
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.. Recalled by Inspire Medical Systems Inc.. Units affected: 152 units.
Why was this product recalled? ▼
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0040-2025.
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