Despite the pause, the company clarified that the suspension does not impact commercial activity outside the US.

Johnson & Johnson MedTech has temporarily paused all U.S. external evaluations and cases using its Varipulse pulse field ablation (PFA) system

“On January 5, out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four reported neurovascular events in the U.S. External Evaluation,” the company said in its notice.

(Reuters) -Johnson & Johnson said on Wednesday it had temporarily paused the rollout of its Varipulse heart device in the United States, as the company investigates four reported stroke events. The Manufacturer and User Facility Device Experience (MAUDE),