Coapt Dome Electrode, Gen2 system, cutaneous electrode
This recall is currently active, issued October 31, 2023. It was issued by Coapt Llc.
- Company
- Coapt Llc
- Recall Initiated
- October 2, 2023
- Posted
- October 31, 2023
- Recall Number
- Z-0203-2024
- Quantity
- 247 devices
- Firm Location
- Chicago, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
Root Cause
Process design
Action Taken
Coapt, LLC issued a Medical Device Correction notice to its consignees on 10/02/2023 via email. The notice explained the problem, risk, and urged users to take precautions as described in the most recent handbook: https://coaptengineering.com/clinicians. The handbook is under "Downloadable product handbooks."