Coapt Dome Electrode Gen2 System Recalled for Burn Risk
Coapt LLC is recalling the Dome Electrode Gen2 system due to potential burns or blistering from exposure to sunlight, warm temperatures exceeding 12 hours, or battery damage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device recall for potential burns or blistering from thermal exposure or battery damage. As a Class II recall with theoretical harm and no reported injuries, it meets the High severity criterion per the rubric.
Plain-English summary
Coapt LLC is recalling the Dome Electrode, Gen2 system, a cutaneous electrode medical device. The recall involves 247 devices distributed worldwide, including the United States and Sweden.
The device may cause minor burns or blistering if exposed to direct sunlight and/or warm temperatures for over 12 hours, or if the battery is damaged. This hazard has prompted the recall.
The U.S. Food and Drug Administration classified this as a Class II medical device recall.
The recalled product
- Product
- Coapt Dome Electrode, Gen2 system, cutaneous electrode
- Manufacturer
- Coapt LLC
- Hazard
- burn
- thermal-hazard
- battery-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI +B618E0/$+201907E00256B
- all Gen2 system serial number
Distribution
Distributed nationwide across the United States.
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