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U.S. Department of Health and Human Services

Class 1 Device Recall Inspire Model 3028 Implantable Pulse Generator (IPG)

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 Class 1 Device Recall Inspire Model 3028 Implantable Pulse Generator (IPG)see related information
Date Initiated by FirmMay 16, 2024
Date PostedJune 21, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2159-2024
Recall Event ID 94658
PMA NumberP130008S103 
Product Classification Stimulator, hypoglossal nerve, implanted, apnea - Product Code MNQ
ProductInspire Model 3028, IV Implantable Pulse Generator
Code Information 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
FEI Number 3007666314
Recalling Firm/
Manufacturer		 Inspire Medical Systems Inc.
5500 Wayzata Blvd Ste 1600
Golden Valley MN 55416-1237
For Additional Information Contact
763-205-7974
Manufacturer 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,
FDA Determined
Cause 2		Process control
ActionInspire 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.
Quantity in Commerce24 devices
DistributionWorldwide distribution - US Nationwide and the country of Germany.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MNQ
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