Coapt LLC: Medical Device Recall in 2023 - (Recall #: Z-0203-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Coapt Dome Electrode, Gen2 system, cutaneous electrode

Product Classification:

Class II

Date Initiated: October 2, 2023

Date Posted: November 8, 2023

Recall Number: Z-0203-2024

Event ID: 93137

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.

Status: Ongoing

Product Quantity: 247 devices

Code Information:

UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated