The FDA ruled that this is a Class I recall due to the significant risks for patients. Customers are not required to return the devices, however. Inari Medical has provided updated warnings and recommendations that should be followed. 

Researchers combined data from three well-known clinical trials—NOTION, Evolut Low Risk and PARTNER 3—and evaluated thousands of low-risk patients who presented with severe aortic stenosis. 

Regulators emphasized that these devices should not be used due to significant safety risks. 

Researchers tracked patients undergoing elective cardiac surgery at a high-volume medical center, treating 50% of the selected cohort with above-average oxygen levels.

The A-Flux Reducer System by VahatiCor was designed to “conform seamlessly” to any patient’s anatomy, and it can be repositioned or retrieved as necessary.

The management of stable angina has been evolving at a rapid rate. Using a one-size-fits-all strategy is becoming a thing of the past, replaced by a patient-centered approach that requires open communication and a healthy understanding of recent clinical research.

Both patients and physicians were impacted by the incident, with outside forces gaining access to everything from names and social security numbers to banking information. 

A care team in Germany has completed what may be the first structural heart procedure of its kind on a high-risk patient. It started as a straightforward heterotopic caval valve implantation, but then paravalvular leak resulted in a change of plans.