FDA recall Z-0203-2024

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

Status

Ongoing

Initiation date

2023-10-02

Report date

2023-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chicago, IL, United States

Primary source

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