Z-0203-2024Class II

Coapt Dome Electrode, Gen2 system, cutaneous electrode

Name: Z-0203-2024 Coapt Dome Electrode, Gen2 system, cutaneous electrode
Creator: Coapt LLC
Published: 2023-10-02
License: https://open.fda.gov/license/

Coapt LLC / initiated 2023-10-02 / Open, Classified / root cause: manufacturing process

FDA source

Coapt LLC began a recall of Coapt Dome Electrode, Gen2 system, cutaneous electrode on 2023-10-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0203-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-02
Posted: 2023-10-31
Recalling firm: Coapt LLC
Product: Coapt Dome Electrode, Gen2 system, cutaneous electrode
Product code: GXY Electrode, Cutaneous
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0203-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0203-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-10-31

Product code GXY

K190416Class IIDome ElectrodeCoapt, LLC / cleared 2019-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)