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Genio System 2.1

Nyxoah · Model Genio Activation Chip Model #2364 · UDI-DI 05404031024847

MNQ Prescription
0
510(k) clearances
3,571
Adverse events (4 deaths)
6
Recalls
15
Facilities

Description

The Activation Chip is the power source for the Implantable Stimulator. The Activation Chip contains a rechargeable battery, electronics for Bluetooth communication and electromagnetic power transmission, and a microprocessor that stores the user-specific stimulation parameters. The Activation Chip must be connected to the Disposable Patch and placed on the chin each night for stimulation to be delivered, and the battery must be recharged daily.

Recalls

DateFirmReason
2026-05-11Inspire 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
2026-05-11Inspire 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
2024-07-31Inspire 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.
2024-07-31Inspire 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.
2024-05-16Inspire 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
2018-06-12Inspire Medical Systems Inc.Incorrect use-by date on the device registration/patient file labels.

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Data 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.