Reported Jul 3, 2024 · Ongoing
Inspire Model 3028, IV Implantable Pulse Generator
Inspire Medical Systems Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 3028, IV Implantable Pulse Generator
- Lot codes and dates
- USUDI/DI 0855728005915
- Serial Numbers
AIR324492CAIR324500CAIR324506CAIR324510CAIR324518CAIR324523CAIR324493CAIR324502CAIR324507CAIR324511CAIR324520CAIR324494CAIR324503CAIR324508CAIR324515CAIR324521CAIR324496CAIR324504CAIR324509CAIR324517CAIR324522C
- EuropeUDI/DI 10855728005847
- Serial Numbers
AIR324497CAIR324499CAIR324505C
- Amount recalled
- 24 devices
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
Using this product could cause serious injury, illness or death — stop using it now.
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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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