Reported Oct 16, 2024 · Ongoing
Inspire Model 4063 Stimulation 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 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
- Lot codes and dates
- Model 4063
- UDI-DI10855728005793
- Part Number900-013-001
- Serial Numbers
457 of 457 codes
T52648T52644T52642T52640T52635T52630T52634T52615T52611T52654T52655T52607T52604T52609T52603T52595T52597T52616T52594T52591T52590T52592T52612T52588T52625T52579T52566T52561T52522T52523T48445T48424T48403T48388T48357T48352T48345T48340T48331T48332T48333T48288T11952T11955T48282T48265T48255T48253T48254T48217T48188T48184T48167T48189T48213T48166T48161T48153T48149T48144
- Amount recalled
- 457 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.
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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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