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

FDA device recall Z-1205-2025 · posted 2025-02-28 · Open, Classified

Recall details

Recalling firm

Biosense Webster, Inc.

Reason for recall

Due to an observed trend of neurovascular events

Action taken

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

Root cause

Labeling design

Status

Open, Classified

Product code

QZI

Quantity affected

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

Date initiated

2025-01-05

Date posted

2025-02-28

Location

Irvine, CA