Biosense Webster, Inc. recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is ind…
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Labeling design
Reason for recall
Due to an observed trend of neurovascular events
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 SystemUDI-DI code
What the firm is doing
On 01/05/2025, the firm called and emailed customers to inform them to pause the US External Evaluations and all Varipulse cases due an observed trend in neurovascular events associated with the use of the VariPulse Bi-Directional Ablation Catheters distributed between December 2024 and January 2025. For U.S. Customers, Biosense Webster/JNJ Medtech EP is pausing the US External Evaluation and all US Varipulse cases. Healthcare providers who have treated patients using the products prior to the pause should continue to follow those patients according to their standard of care. For any questions, contact Biosense Webster/JNJ MEDTECH EP representatives On 01/08/2025, the firm released the information on the firm's parent company's website https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-varipulse-u-s-external-evaluation
DistributionShow detailsHide
Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and TX. EMEA, New Zealand, Saudi Arabia, Oman, United Ecuador, Panama, South Africa, China Austria Belgium Czech Republic France Germany Hungary Ireland Israel Italy UK Sweden Norway Denmark Finland Luxembourg Netherlands Poland Portugal Slovenia Spain Switzerland Serbia United Arab Emirates Croatia Canada South Korea Japan
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1205-2025
- FDA device classification · QZIOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Biosense Webster, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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