Inspire Medical Systems is recalling 24 Inspire Model 3028 IV Implantable Pulse Generators (IPGs) because of a manufacturing defect that can cause electrical leakage in the device's sensing circuit. This defect leads to a system malfunction, preventing the device from working correctly. Because this device is implanted, a failure requires a revision surgery to remove and replace the pulse generator. Consumers should contact their healthcare provider immediately to determine if their specific implant is one of the 24 affected units.
The defect allows electricity to leak within the sensing circuit, which can cause the device to stop functioning as intended. This malfunction requires patients to undergo an additional surgical procedure to replace the faulty implant, posing risks associated with surgery and the loss of therapy.
Revision surgery for device replacement.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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