FDAOctober 2, 2023device
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
coapt
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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