Coapt Dome Electrode, Gen2 system, cutaneous electrode recallZ-0203-2024 · Coapt LLC · initiated Oct 2, 2023
Class II Open, Classified All recalls posted in October 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Coapt LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
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."
Recall details
- Recall number
- Z-0203-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Oct 2, 2023
- Posted by the FDA
- Oct 31, 2023
- Recalling firm
- Coapt LLC
- Quantity
- 247 devices
- Product code
- GXY
- FDA submissions
- K190416
- Distribution
- Worldwide distribution - US Nationwide and the country of Sweden.
Product description
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Code information (models, lots, serial numbers)
UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
Other devices under the same FDA submission
1 device cleared under K190416 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dome Electrodes 1Coapt LLC · Electrode, Cutaneous1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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