Cerenovus recalls CEREPAK Detachable Coil Systems (model numbers listed) due to risk of stroke from coils failing to detach during use. Affected units manufactured before August 2025.
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
Cerenovus is recalling specific CEREPAK Detachable Coil Systems that may fail to detach, potentially causing stroke or requiring additional surgery. This is serious and requires immediate action to avoid health risks.
The detachable coils in these systems can fail to separate properly during medical procedures, leading to bleeding (hemorrhagic stroke) or blocked blood flow (ischemic stroke). This may also cause procedural delays or require additional surgery.
Patients who have received the recalled CEREPAK Detachable Coil Systems for aneurysm treatment are affected. Those with the specific model numbers listed in the recall are at highest risk.
Check the product name and model number on the device. Affected units include specific sizes like UNIFORM 2MM X 2.5 CM/FCX100202 and others listed in the recall. All devices manufactured prior to and including August 2025 are affected.
Immediately stop using the recalled CEREPAK Detachable Coil System if you have it. Do not attempt to repair or continue using it.
The CEREPAK Detachable Coil System is a medical device used to treat brain aneurysms by placing coils to stop bleeding.
All CEREPAK Detachable Coil Systems with model numbers listed in the recall, including UNIFORM 2MM X 2.5 CM/FCX100202 and others up to August 2025.
Check the model number on your device. Affected units were manufactured prior to and including August 2025, with specific model numbers listed in the recall.
We’ve drafted a message you can send Cerenovus to request your refund or repair — edit it as you like.
Subject: Recall Z-0434-2026 — Cerenovus Cerenovus Hello, I own a Cerenovus that is covered by recall Z-0434-2026 from Cerenovus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
