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Coapt LLC recalls Coapt ControlSeal Electrode, cutaneous EMG Electrode
Recalled November 8, 2023 · FDA recall Z-0204-2024 · 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
109 devices
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, Canada, and 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 ControlSeal Electrode, cutaneous EMG Electrode
Manufacturer(s)
Coapt LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →