Reported Oct 16, 2024 · Ongoing
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Inspire Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inspire Medical Systems Inc. · 5500 Wayzata Blvd Ste 1600 · Golden Valley, MN · 55416-1237
Is this the product you have?
- Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
- Lot codes and dates
- Model 4340
- UDI-DI10855728005946
- Part Number900-014-00
- Serial Numbers
152 of 152 codes
D59544D59550D59543D59541D59542D59528D59526D59534D59521D59477D59519D59515D59516D59489D59514D59512D59510D59509D59547D59549D59505D59506D59504D59503D59502D59529D59497D59494D59490D59485D59486D56077D56072D56064D56060D56059D56055D56038D56082D56035D56044D56031D56032D56033D56034D56040D56046D56030D56036D56053D56054D56058D55284D48681D48668D48661D48655D48650D48410D46477
- Amount recalled
- 152 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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