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Open, Classified

Coapt ControlSeal Electrode, cutaneous EMG Electrode

FDA Recall Z-0204-2024 · Posted 2023-10-31

Recalling FirmCoapt LLC
Recall StatusOpen, Classified
Product CodeGXY
Date Initiated2023-10-02
Product Quantity109 devices

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.

Firm Action

Coapt, LLC issued a Medical Device Correction notice to its consignees on 10/02/2023 via email. The notice explained the problem, risk, and urged users to take precautions as described in the most recent handbook: https://coaptengineering.com/clinicians. The handbook is under "Downloadable product handbooks."

Root Cause

Process design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Sweden.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K223605ControlSeal Electrode (ELSB)Coapt · 2022-12-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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