CardioFocus, Inc. 2025-03-19 Health serious FDA
Health · FDA · Recall #FDA-Z-1307-2025
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It… Recall
Issued March 19, 2025 · CardioFocus, Inc.
In March 2025, CardioFocus, Inc. recalled the CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
What you should do
- 1 Stop using CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact CardioFocus, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- CardioFocus, Inc.
- Category
- Health
- Recall date
- March 19, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.
- Recall number
- FDA-Z-1307-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- CardioFocus, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.