Coapt LLC 2023-11-08 Health serious FDA
Health · FDA · Recall #FDA-Z-0203-2024
Coapt Dome Electrode, Gen2 system, cutaneous electrode Recall
Issued November 8, 2023 · Coapt LLC
In November 2023, Coapt LLC recalled the Coapt Dome Electrode, Gen2 system, cutaneous electrode, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Coapt Dome Electrode, Gen2 system, cutaneous electrode right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Coapt LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Coapt LLC
- Category
- Health
- Recall date
- November 8, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the country of Sweden.
- Recall number
- FDA-Z-0203-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Coapt LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.