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.

In that single-arm study, the rate of primary adverse events within 7 days of ablation was 2.9%, with the most common complication being pericardial tamponade (1.1%), and a few cases of stroke (0.7%) and transient ischemic attack (0.4%).

Johnson & Johnson has announced a temporarily pause in the rollout of its Varipulse heart device in the United States as it investigates four reported stroke events. The decision comes

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

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.