FDA Device recall Z-0203-2024
Coapt Dome Electrode, Gen2 system, cutaneous electrode
- FDA Device
- Class II
- ongoing
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class II recall of Coapt Dome Electrode, Gen2 system, cutaneous electrode by Coapt, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0203-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-02 |
| Published | 2023-11-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coapt |
| Distribution | US |
Product
Coapt Dome Electrode, Gen2 system, cutaneous electrode
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.
Identifiers
| code_info | UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0203-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.