Genio System 2.1
Nyxoah · Model Genio External Stimulator · UDI-DI 05404031018693
MNQ
Prescription
0
510(k) clearances
3,486
Adverse events (4 deaths)
6
Recalls
15
Facilities
Description
The External Stimulator is a single-use, sterile accessory that allows the surgeon to activate the Implantable Stimulator and verify the functionality of the implant during the surgical procedure. The External Stimulator contains a power button with an LED indicator, a pre-charged battery and a retractable scaling mechanism to control the stimulation intensity delivered to the implant.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-11 | Inspire Medical Systems Inc. | Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D |
| 2026-05-11 | Inspire Medical Systems Inc. | Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D |
| 2024-07-31 | Inspire Medical Systems Inc. | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| 2024-07-31 | Inspire Medical Systems Inc. | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| 2024-05-16 | Inspire Medical Systems Inc. | 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 t |
| 2018-06-12 | Inspire Medical Systems Inc. | Incorrect use-by date on the device registration/patient file labels. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.