Coapt LLC is recalling 247 Coapt Dome Electrode components used in Gen2 prosthetic systems. The recall was initiated because the cutaneous electrodes may cause minor burns or blistering if the device is exposed to direct sunlight or warm temperatures for more than 12 hours, or if the battery becomes damaged. This issue affects units distributed worldwide, including across the United States and in Sweden. Owners should contact their healthcare provider or Coapt LLC for further instructions regarding this equipment defect.
Extended exposure to heat or sunlight can cause the electrode to overheat against the user's skin, potentially resulting in minor burns or skin blistering.
Healthcare provider or manufacturer consultation
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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