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All product recalls associated with Inspire Medical Systems Inc..
Total Recalls
3
Past Year
0
Class I (Serious)
0
Most Recent
Jul 2024
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
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,