Inspire Model 3028 Implantable Pulse Generator Manufacturing Defect
Inspire Medical Systems recalls the Model 3028 Implantable Pulse Generator due to a manufacturing defect causing electrical leakage and system malfunction that requires revision surgery. The recall affects 24 devices distributed in the US and Germany.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which establishes a minimum severity of 4 per the rubric. The manufacturing defect causes system malfunction requiring revision surgery in an implantable medical device, though no reported illnesses or injuries are stated in the source text.
Plain-English summary
Inspire Medical Systems Inc. is recalling the Model 3028 Implantable Pulse Generator due to a manufacturing defect in the sensing circuit. The defect can cause electrical leakage, leading to system malfunction that requires revision surgery to replace the device.
The recall affects 24 devices with specific serial numbers. Distribution includes the United States and Germany. Patients who have received this device should contact their healthcare provider immediately for evaluation and guidance on appropriate next steps.
The recalled product
- Product
- Inspire Model 3028, IV Implantable Pulse Generator
- Manufacturer
- Inspire Medical Systems Inc.
- Category
- Medical Device
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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