Coapt Dome Electrode recall
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Why was Coapt Dome Electrode recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
- Product
- Coapt Dome Electrode, Gen2 system, cutaneous electrode
- Recalling firm
- Coapt LLC
- Quantity
- 247 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Sweden.
- Recall date
- November 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)