Medtronic is recalling 440 units of various Implantable Cardioverter Defibrillator (ICD) models, including Cobalt, Crome, Evera, Mirro, and Primo series devices, due to a potential manufacturing defect. A crack in a weld was identified during the manufacturing process that could lead to device failure. Because these devices are implanted to monitor and treat life-threatening heart rhythms, a failure of the device to operate correctly could lead to serious medical complications. Consumers should contact their healthcare provider immediately to determine if their specific implanted device is affected by this recall.
The weld crack defect can cause the device to fail its hermetic seal, potentially leading to internal component failure and the inability to provide life-saving electrical therapy for heart rhythm disorders. While the defect was caught during manufacturing leak checks, some potentially affected units were distributed and may fail while implanted.
Healthcare provider consultation and technical assessment
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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