Coapt Dome Electrode, Gen2 system, cutaneous electrode
FDA device recall Z-0203-2024 · posted 2023-10-31 · Open, Classified
Recall details
- Recalling firm
- Coapt LLC
- 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.
- 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."
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- GXY
- Quantity affected
- 247 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Sweden.
- Date initiated
- 2023-10-02
- Date posted
- 2023-10-31
- Location
- Chicago, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Dome Electrode (K190416) | Coapt, LLC | 2019-04-04 |