Z-2159-2024Class I

Inspire Model 3028, IV Implantable Pulse Generator

Name: Z-2159-2024 Inspire Model 3028, IV Implantable Pulse Generator
Creator: Inspire Medical Systems Inc.
Published: 2024-05-16
License: https://open.fda.gov/license/

Inspire Medical Systems Inc / initiated 2024-05-16 / Open, Classified / root cause: manufacturing process

FDA source

Inspire Medical Systems Inc. began a recall of Inspire Model 3028, IV Implantable Pulse Generator on 2024-05-16. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2159-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-05-16
Posted: 2024-06-21
Recalling firm: Inspire Medical Systems Inc
Product: Inspire Model 3028, IV Implantable Pulse Generator
Product code: MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
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,
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected].
Quantity in commerce: 24 devices
Distribution: Worldwide distribution - US Nationwide and the country of Germany.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2159-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2159-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-21

Product code MNQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)