(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),

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

Just months after FDA approval, Johnson & Johnson paused the rollout of its Varipulse pulsed field ablation (PFA) platform in the U.S. due to safety reasons. In a U.S. external evaluation cohort, four reported neurovascular events occurred among over 130 cases across 14 sites and 40 operators.

“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.

Johnson & Johnson shares are down 3% Wednesday on safety concerns that could dim sales prospects for a new heart device, while its rivals gained. J&J said it temporarily paused the use of the heart device,

Johnson & Johnson said on Wednesday it temporarily paused the rollout of its Varipulse heart device in the United States as the company investigates four reported stroke events.

Johnson & Johnson said on Wednesday it has temporarily paused the rollout of its Varipulse heart device in the United States, citing an abundance of caution as the company investigates four reported stroke events.

Johnson & Johnson’s JNJ MedTech unit has temporarily paused sales of Varipulse, its pulsed field ablation (PFA) therapy to treat atrial fibrillation (AFib) in the United States, as it investigates four reported cases of neurovascular events.