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U.S. Department of Health and Human Services

Class 2 Device Recall Coapt Dome Electrodes

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  Class 2 Device Recall Coapt Dome Electrodes see related information
Date Initiated by Firm October 02, 2023
Date Posted October 31, 2023
Recall Status1 Open3, Classified
Recall Number Z-0203-2024
Recall Event ID 93137
510(K)Number K190416  
Product Classification Electrode, cutaneous - Product Code GXY
Product Coapt Dome Electrode, Gen2 system, cutaneous electrode
Code Information UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
Recalling Firm/
Manufacturer		 Coapt LLC
303 W Institute Pl Ste 200
Chicago IL 60610-3080
For Additional Information Contact
844-262-7800
Manufacturer 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.
FDA Determined
Cause 2		 Process design
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."
Quantity in Commerce 247 devices
Distribution Worldwide distribution - US Nationwide and the country of Sweden.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GXY and Original Applicant = Coapt, LLC
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