Chicago, IL, United States
Coapt LLC recalls
2 recalls recorded since 2018, most recently on 2 October 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 October 2023
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the country of Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0203-2024
- Coapt Dome Electrode, Gen2 system, cutaneous electrode
Ongoing Class II Medical devices
- Recall started
- 2 October 2023
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0204-2024
- Coapt ControlSeal Electrode, cutaneous EMG Electrode
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.