CardiFocus Heartlight X3 Cardiac Catheter Sterile Barrier Damage Recall
CardioFocus is recalling 833 units of CardiFocus Heartlight X3 cardiac catheters due to potential damage to the sterile barrier pouch that could compromise product sterility. Affected units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (cardiac catheter with sterile barrier compromise) where no injury has been reported. The FDA Class II classification and potential for infection from a compromised sterile barrier on an invasive cardiac device warrant a High severity rating per the rubric.
Plain-English summary
CardioFocus, Inc. is recalling CardiFocus Heartlight X3 Cardiac Catheter (Model 18-5000) due to potential damage to the sterile barrier pouch. This damage could compromise the catheter's sterility. The FDA issued this Class II recall under number Z-1307-2025.
The recall affects 833 units distributed worldwide, including throughout the United States and to Belgium, Czech Republic, Italy, Japan, and the United Kingdom. The affected units include specific serial numbers for products distributed from January 2024 to January 2025. The product is intended for treatment of atrial fibrillation and is used in electrophysiology or catheterization laboratory settings.
Healthcare providers and patients who have received affected units should contact CardioFocus, Inc. or their healthcare provider immediately. Affected catheters should not be used. Healthcare facilities should check their inventory against the serial number list provided by the manufacturer.
The recalled product
- Product
- CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000
- Manufacturer
- CardioFocus, Inc.
- Affected units
- 833
Distribution
Distributed nationwide across the United States.
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