Dozens of customers have reported issues with the device’s balloon or catheter hub separating from the delivery system, mostly during off-label use in a patient's blood vessels.

Researchers aimed to shine light on this key topic, tracking data from nearly 200,000 patients. 

The collaboration is aimed at improving patient outcomes after cardiac surgeries and other procedures. 

Catch up on several recent FDA announcements, including an update on the agency's response to the COVID-19 pandemic. 

"For clinicians, suspicion for valve diseases should be increased and evaluations carefully performed for patients with MAC," according to one Mayo Clinic cardiologist.

Production at the facility in Shanghai is expected to be near 100% starting on June 6.