# FDA recall Z-0203-2024

> **Coapt LLC** · Class II · device recall initiated 2023-10-02.

## Product

Coapt Dome Electrode, Gen2 system, cutaneous electrode

## 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.

## Key facts

- **Recall number:** Z-0203-2024
- **Recalling firm:** Coapt LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-02
- **Report date:** 2023-11-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2024

## Citation

> AI Analytics. FDA recall Z-0203-2024. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0203-2024. Source: US FDA. Licensed CC0.

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