Cerenovus Inc. is recalling 12,004 units of CEREPAK Detachable Coil Systems because the coils may fail to detach from the delivery system during medical procedures. This recall affects a wide range of models, including UNIFORM, FREEFORM, and HELIFORM SOFT variants manufactured on or before August 2025. The failure of a coil to detach during a procedure to treat an aneurysm or other vascular issue can lead to serious patient harm.
A failure in the detachment system can result in severe complications including hemorrhagic or ischemic stroke, significant procedural delays, or the need for additional surgical intervention to resolve the issue. These complications can be life-threatening or result in long-term disability.
All devices/lots manufactured prior to and including August 2025 are affected.
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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