Class I - Dangerous
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Inspire Medical Systems
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Class I - Dangerous
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Class I - Dangerous
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,
Incorrect use-by date on the device registration/patient file labels.