This is a Class I recall, which means using the devices “may cause serious injuries or death.” The catheter's instructions have been updated to reduce the risk of complications going forward. 

The latest Class I recall is due to mechanical issues that can cause the devices to stop charging their batteries. 

“This situation unacceptably exacerbates the interventional cardiology workforce shortage and threatens to directly impact the care of patients," SCAI wrote in a new statement. 

This latest recall was brought on by electrical failures and includes more than 4,500 devices. There have been 26 complaints due to the issue but no reported injuries or deaths. 

The agency has shared a new draft guidance focused on the inclusion of information related to QTc interval prolongation. 

The system includes an expandable cryoablation balloon catheter compatible with multiple balloon sizes. 

Using these devices as part of a zero-fluoroscopy workflow, which replaces X-rays with an alternative modality such as ultrasound, limits radiation exposure and the use of burdensome protective equipment.

Valentin Fuster, MD, PhD, one of the world’s most prominent cardiologists, said "it is now our responsibility to ensure these treatments are widely available and used by the medical community.”