This is a Class I recall, according to the FDA. Care teams may need to send in their equipment so that specific hardware updates can be performed.

Devi Nair, MD, spoke to Cardiovascular Business about her own experience using concomitant LAA occlusion as an add-on to catheter ablation procedures.

The issue at the heart of this recall has been linked to three patient deaths. 

Researchers explored data from nearly 800 patients, focusing on a wide variety of outcomes.

Kenneth Bilchick, MD, spoke to Cardiovascular Business about new data he presented at Heart Rhythm 2026. 

LVOT obstruction is a serious complication of TMVR. BATMAN may help protect patients from LVOT obstruction without leading to any additional risks.

TAVR procedures with a higher implant depth are associated with certain clinical benefits after one year, according to a new study of data from more than 600 patients.

“Technology grows and grows,” as one lab director explained. “Our job is to keep up with it and use it in the most efficient and effective way.”

As TAVR continues to gain popularity, researchers remain focused on discovering new ways to predict short- and long-term outcomes. One recent study, for example, explored the potential of AI-enabled imaging assessments. Another analysis focused on the CALLY index.

The FDA first shared a warning about this issue back in April. Now, the agency has shared a critical update. 

The American College of Radiology is seeking to revive the shelved AUC program, while nuclear cardiologists are speaking against these efforts. 

The change would represent an imperfect but, in many cases, perfectly appropriate way to oversee the technology without crimping its capabilities. So say three thought leaders who are close watchers of medical ethics and technologies.