FDA Medical Device Recalls (openFDA)
Coapt LLC: Coapt Dome Electrode, Gen2 system, cutaneous electrode
- Recall number
- Z-0203-2024
- Recalling firm
- Coapt LLC
- Product
- Coapt Dome Electrode, Gen2 system, cutaneous electrode
- Status
- Open, Classified
- Initiated
- 2023-10-02
- Posted
- 2023-10-31
- Terminated
- not on file
- 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.
- Root cause
- Process design
- Action
- 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."
- Quantity
- 247 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Sweden.
- Lot, serial or model codes
- UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
- 510(k) numbers
- ["K190416"]
- PMA numbers
- not on file
- Product code
- GXY
- Firm FEI
- 3010605876
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28