Inspire Model 3028, IV Implantable Pulse Generator
This recall is currently active, issued June 21, 2024. It was issued by Inspire Medical Systems Inc..
- Company
- Inspire Medical Systems Inc.
- Recall Initiated
- May 16, 2024
- Posted
- June 21, 2024
- Recall Number
- Z-2159-2024
- Quantity
- 24 devices
- Firm Location
- Golden Valley, MN
- Official Source
- View on FDA website ↗
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.
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
Root Cause
Process control
Action Taken
Inspire Medical systems issued an URGENT Medical Device Correction notice to the affected healthcare providers on 05/16/2024 via FedEx overnight. The notice explains the potential problem with the device and risk to the patient and recommends the following actions: We recommend the following actions: " Notify affected patients of this voluntary recall. " Schedule your patient for a monitoring visit to confirm their Inspire therapy is working as intended through waveform and impedance analysis. Monitor patients for reports of variation in stimulation, a lack of therapy effectiveness, or an inability to turn on therapy. " Continue with routine monitoring and conduct waveform and impedance analysis at every routine office visit, as IPG issue may be non-invasively identified with basic waveform and impedance testing. " If abnormal waveforms or impedances are observed, record impedance values at 1.5V, 2.0V, 2.5V, 3.0V and 3.5V. o Let the patient know they will feel 3 short pulses of stimulation. o Some of these stimulation pulses may feel strong. This is normal. " Contact your Inspire representative for additional diagnostic testing and troubleshooting recommendations. For additional questions: please contact your Inspire representative or the Inspire Quality team at ProductRecalls@inspiresleep.com.