Coapt recalls ControlSeal Electrodes due to potential minor burns or blisters from prolonged sunlight or heat exposure. Affected units sold with specific serial numbers.
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 ControlSeal Electrodes because they can cause minor burns or blisters if left in direct sunlight or warm temperatures for more than 12 hours, or if the battery is damaged. This risk is low but requires proper storage to avoid injury.
The device can overheat or cause skin damage if exposed to direct sunlight or high temperatures for more than 12 hours. Battery damage may also lead to minor burns or blisters.
Patients using the Coapt ControlSeal Electrodes for medical monitoring are affected. Those storing the device in warm or sunny areas are at higher risk.
Check for the serial number on the device, which starts with +B618P1/$+202210P1603. All units with this specific UDI/DI code are affected.
Ensure the device is kept in a cool, dark place away from direct sunlight and heat sources.
No, the device is safe when stored in a cool, dark place and not exposed to direct sunlight or high temperatures for more than 12 hours.
Battery damage can cause minor burns or blisters, so check for signs of damage and avoid using the device if the battery is compromised.
Look for the serial number starting with +B618P1/$+202210P1603 on the device label.
We’ve drafted a message you can send Coapt to request your refund or repair — edit it as you like.
Subject: Recall Z-0204-2024 — Coapt Coapt Hello, I own a Coapt that is covered by recall Z-0204-2024 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.
