FDA-Device2024-07-03Class I
Inspire Model 3028, IV Implantable Pulse Generator
Inspire Medical Systems Inc.
Hazard
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,
Sold states
Worldwide distribution - US Nationwide and the country of Germany.
Affected count
24 devices
Manufactured in
5500 Wayzata Blvd Ste 1600, Golden Valley, MN, United States
Products
Inspire Model 3028, IV Implantable Pulse Generator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief