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# J&J Pauses Varipulse Rollout
- URL: https://www.fdaweb.com/j-j-pauses-varipulse-rollout/
- Published: 2025-01-09T12:00:00.000Z
- Updated: 2026-09-14T14:50:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158462

Johnson & Johnson says it has paused the U.S. external evaluation and all U.S. Varipulse cases while it investigates the root cause of four reported neurovascular events in the U.S. external evaluation. A company [statement](https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-varipulse-u-s-external-evaluation?ref=fdaweb.com) says that since beginning the external evaluation cases with the Varipulse platform in the U.S., the company has completed more than 130 cases across 14 sites and 40 operators.

Reuters [reports](https://www.reuters.com/business/healthcare-pharmaceuticals/jj-pauses-rollout-heart-device-us-investigate-stroke-risk-2025-01-08/?source=email) that an external evaluation is a limited rollout intended to collect doctors’ feedback on a new technology before a broader full release. Varipulse uses a pulsed field ablation technique to treat certain abnormal heart rhythm conditions, it says. The technology was approved by FDA in 11/2024.