CardioFocus, Inc. recalls CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an…
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Read the official notice →- Date
- 2025-03-19
- Country
- United States
- Brand
- CardioFocus, Inc.
- Product
- CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Belgium, Czech…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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