FDA Recalls VARIPULSE Bi-Directional Ablation Catheter Due to Neurovascular Events
Biosense Webster is recalling VARIPULSE Bi-Directional Ablation Catheters (REF D141201) due to an observed trend of neurovascular events. The FDA issued a Class I recall affecting approximately 497 units distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which requires a minimum severity score of 4 per the rubric. The hazard—neurovascular events—represents a serious medical risk associated with a cardiac ablation device used in high-risk electrophysiological procedures.
Plain-English summary
The VARIPULSE Bi-Directional Ablation Catheter (REF D141201), manufactured by Biosense Webster, Inc., is a cardiac electrophysiological device indicated for use in catheter-based cardiac mapping and, when used with the TRUPULSE Generator, for treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.
The FDA has issued a Class I recall of this device due to an observed trend of neurovascular events.
The recall affects approximately 497 catheter units distributed worldwide. In the United States, 378 units have been distributed to AR, CA, CO, KS, LA, MA, MO, NY, OH, and TX. An additional 119 units have been distributed internationally to multiple countries including Canada, the European Union, and other regions. Specific batch numbers for the affected devices are documented in the recall notice.
Patients and healthcare providers who have these devices should contact Biosense Webster, Inc., or consult the official FDA recall notice (Z-1205-2025) for specific guidance on managing this device and its use.
The recalled product
- Product
- VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent…
- Manufacturer
- Biosense Webster, Inc.
- Hazard
Distribution
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