medical Class II Updated 2023-11-08

Coapt LLC recalls Coapt Dome Electrode, Gen2 system, cutaneous electrode

Recalled Product

Coapt Dome Electrode, Gen2 system, cutaneous electrode


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
View official government recall

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