Coapt LLC Recall 93137
Description: Coapt Dome Electrode, Gen2 system, cutaneous electrode
Coapt LLC Recall 93137 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0203-2024 |
| Event ID | 93137 |
| Event Description | Coapt Dome Electrode, Gen2 system, cutaneous electrode |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Sweden. |
| Quantity | 247 devices |
| Recall 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. |
| Device Classification | 20231108 |
| Device Code Info | UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number |
| Center Classification Date | 20231031 |
| Recall Initiation Date | 20231002 |
| Recalling Firm | Coapt LLC |
| Initial Notification | |
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