Coapt recalls Gen2 Dome Electrodes that may cause minor burns or blisters if left in direct sunlight or warm temperatures for over 12 hours.
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Coapt is recalling its Gen2 Dome Electrodes because they can cause minor burns or blisters if exposed to sunlight or warm temperatures for more than 12 hours. This risk is low but should be avoided to prevent skin irritation.
The device can overheat if left in direct sunlight or warm temperatures for more than 12 hours, potentially causing minor burns or blisters. This happens because the battery may degrade under heat, leading to skin irritation.
People using Coapt Dome Electrodes for medical purposes are affected. Those who leave the device in direct sunlight or warm environments for extended periods are at higher risk.
Check for the Gen2 system with serial numbers starting with B618E0 or the UDI/DI code 201907E00256B. The product was sold with these identifiers.
Ensure the electrode is not exposed to direct sunlight or warm temperatures for more than 12 hours.
No, the recall states only minor burns or blisters are possible.
Look for Gen2 system with serial numbers starting with B618E0 or the UDI/DI code 201907E00256B.
Check if the device has been exposed to direct sunlight or warm temperatures for over 12 hours; if so, avoid using it until the risk is resolved.
We’ve drafted a message you can send Coapt to request your refund or repair — edit it as you like.
Subject: Recall Z-0203-2024 — Coapt Coapt Hello, I own a Coapt that is covered by recall Z-0203-2024 from Coapt. 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.
