Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Coapt Dome Electrode Recalled by Coapt LLC Due to Patient may experience minor burn or blistering if...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Coapt LLC directly.
Affected Products
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Quantity: 247 devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Coapt LLC
Coapt LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report