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

Recalled November 8, 2023 · FDA recall Z-0203-2024 · Coapt

Hazard

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. · FDA Class II

Units

247 devices

Sold at

Worldwide distribution - US Nationwide and the country of Sweden.

Description

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.

Product

Coapt Dome Electrode, Gen2 system, cutaneous electrode

Manufacturer(s)

Coapt LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →