More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible.

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced. 

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.” 

U.S. cardiology groups have worked together to propose the creation of a new American Board of Cardiovascular Medicine for certifying cardiologists. Now, after many months of waiting, a final decision is expected by the end of February. 

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

The difference in atrial fibrillation risk was unexpected, surprising researchers.

Other procedures are associated with higher profits—heart transplants, for instance—but CABG and TAVR are performed much more often.

Johnson & Johnson has reportedly had early discussions with potential buyers about its Cerenovus division of stroke products.

These risks appear to be present regardless of a person's age or health at the time of infection.

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.