PlainRecordsVARIPULSE Bi-Directional Ablation Catheter REF D141201…
- Reason
- Due to an observed trend of neurovascular events
- Status
- Terminated
- 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…
- Enforcement report date
- March 12, 2025
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Terminated (FDA's definition: FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Biosense Webster, Inc.
- 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 symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.
- Reason
- Due to an observed trend of neurovascular events
- Distribution pattern
- 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
- Quantity
- 497 total catheter - 378 US and 119 OUS
- Codes and lots
- 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
- Recall started
- Jan. 5, 2025
- Recall terminated (FDA)
- Oct. 14, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Root cause (FDA)
- Labeling design
- What the company told customers
- 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 number
- Z-1205-2025
What this record is about
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“Due to an observed trend of neurovascular events”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., FDA enforcement report, 2025-03-12. The caption is the record's own words.
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FDA device name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Distributed in (FDA's record): Arkansas California Colorado Kansas Louisiana Massachusetts Missouri New York Ohio Texas
This recall among the others
- FDA's enforcement report came 66 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Biosense Webster: 3 other recalls or notices on this site in the three years before this one (from March 13, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1205-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1205-2025, March 12, 2025. "VARIPULSE Bi-Directional Ablation Catheter REF D141201." PlainRecords, https://plainrecords.com/recall/device/z-1205-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections