VARIPULSE Bi-Directional Ablation Catheter REF D141201 recallZ-1205-2025 · Biosense Webster, Inc. · initiated Jan 5, 2025
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biosense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to an observed trend of neurovascular events
FDA root cause category: Labeling design
What the company 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
Recall details
- Recall number
- Z-1205-2025
- Status
- Completed
- Initiated by the company
- Jan 5, 2025
- Posted by the FDA
- Feb 28, 2025
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 497 total catheter - 378 US and 119 OUS
- Product code
- QZI
- FDA submissions
- P240006
- Distribution
- 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
Product description
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 System.
Code information (models, lots, serial numbers)
Product Number: D141201-12 UDI-DI code: 10846835025460 Batch Numbers: 31483574L 31483560L 31483581L 31483542L 31487313L 31483552L 31483544L 31487311L 31483550L 31483558L 31483575L 31483556L 31487312L 31483553L 31483565L 31483576L 31483547L 31487320L 31483549L 31483561L 31483548L 31483564L 31483541L 31483546L 31483562L 31483566L 31483583L 31483567L
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VARIPULSE™ Bi-Directional Catheter D141201Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall3 deaths273 reports
Other devices under the same FDA submission
2 devices cleared under P240006 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TRUPULSE™ Generator D141702Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation18 reports
- Sterile Interface Cable D133701Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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