Coapt LLC FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Coapt Dome Electrode, Gen2 system, cutaneous electrodeClass IIOct 2, 2023Patient may experience minor burn or blistering if device is	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatur	Class IIDevices	Oct 2, 2023
Coapt ControlSeal Electrode, cutaneous EMG ElectrodeClass IIOct 2, 2023Patient may experience minor burn or blistering if device is	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatur	Class IIDevices	Oct 2, 2023