Reported Sep 12, 2018 · Terminated
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product…
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. · 9700 63rd Ave N Ste 200 · Maple Grove, MN · 55369-6202
Is this the product you have?
- Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020
- Product UsageThe device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA)
- Lot codes and dates
- UDI 10855728005434. The incorrect Use By Date of 2018-01-14 can be found in the literature packet that is in the box with the sterile tray/IPG. The literature packet contains the product/patient manuals, device registration form, and the device registration label set. The 3 large label sticker set with the device registration label set contains the incorrect use-by date.. Affected
- serial numbers in the customer's stock
NCR202227HNCR202230HNCR202238HNCR202244HNCR202245HNCR202246HNCR202247HNCR202252HNCR202253HNCR202254HNCR202255HNCR202259HNCR202260HNCR202261HNCR202264HNCR202266HNCR202267HNCR202268HNCR202269HNCR202270HNCR202272HNCR202273HNCR202274HNCR202275HNCR202276HNCR202277HNCR202278HNCR202279HNCR202281HNCR202282HNCR202283HNCR202284HNCR202285HNCR202287HNCR202294HNCR202306HNCR202307HNCR202314HNCR202315HNCR202317HNCR202320HNCR202324HNCR202325HNCR202328HNCR202336HNCR202337HNCR202338HNCR202339HNCR202466Hand NCR202467H
- Serial numbers implanted
NCR202231HNCR202233HNCR202234HNCR202236HNCR202237HNCR202239HNCR202241HNCR202242HNCR202249HNCR202250HNCR202251HNCR202256HNCR202257HNCR202258HNCR202262HNCR202265HNCR202286HNCR202291HNCR202293HNCR202296HNCR202297HNCR202300HNCR202301HNCR202302HNCR202303HNCR202304HNCR202309HNCR202310HNCR202311HNCR202312HNCR202313HNCR202318HNCR202321HNCR202322HNCR202323HNCR202326HNCR202327HNCR202329HNCR202330HNCR202331HNCR202332HNCR202333Hand NCR202334H
- Amount recalled
- 93 devices
Where it was sold
Why it was recalled
Incorrect use-by date on the device registration/patient file labels.
This product could cause temporary or reversible health problems — stop using it.
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