Summary
The FDA issued a Class I for Inspire Model 3028, IV Implantable Pulse Generator by Inspire Medical Systems Inc.. Reason: There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a.
Details
Source
Device Recall
External ID
Z-2159-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
Product Description
Inspire Model 3028, IV Implantable Pulse Generator
Lot/Code Info: US: UDI/DI 0855728005915, Serial Numbers: AIR324492C, AIR324500C, AIR324506C, AIR324510C, AIR324518C, AIR324523C, AIR324493C, AIR324502C, AIR324507C, AIR324511C, AIR324520C, , AIR324494C, AIR324503C, AIR324508C, AIR324515C, AIR324521C, AIR324496C, AIR324504C, AIR324509C, AIR324517C, AIR324522C; Europe: UDI/DI 10855728005847, Serial Numbers: AIR324497C, AIR324499C, AIR324505C
Quantity Affected: 24 devices
Reason for Recall
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,
Distribution
Worldwide distribution - US Nationwide and the country of Germany.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-16
Company
Golden Valley, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 167 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Inspire Medical Systems Inc. has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Inspire Medical Systems Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Inspire Medical Systems Inc. have FDA actions?
Inspire Medical Systems Inc. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2159-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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