Inspire Medical Systems Inc.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Inspire Medical Systems Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-10-16FDA-DeviceClass IIInspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
- 2024-10-16FDA-DeviceClass IIInspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
- 2024-07-03FDA-DeviceClass IInspire Model 3028, IV Implantable Pulse Generator
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,
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