Z-1205-2025Class I

VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter...

Name: Z-1205-2025 VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter...
Creator: Biosense Webster, Inc.
Published: 2025-01-05
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2025-01-05 / Open, Classified / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping... on 2025-01-05. FDA classified it as Class I and gives the reason as "Due to an observed trend of neurovascular events". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1205-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-01-05
Posted: 2025-02-28
Recalling firm: 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.
Product code: QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Reason for recall: Due to an observed trend of neurovascular events
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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
Quantity in commerce: 497 total catheter - 378 US and 119 OUS
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 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1205-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1205-2025	Class I	Completed	Voluntary: Firm initiated	2025-03-12	2025-02-28

Product code QZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)