Customers are urged to examine their inventory, quarantine any unused products and return them to the manufacturer. 

Three patient deaths have been linked to connectivity issues with these devices. The FDA has classified this as a Class I recall.

Healthcare policies have rapidly evolved in recent years, and 2025 was no exception. From payment policies to physician shortages, ASE and other medical societies had plenty to fight for throughout the year.

There is a risk that these catheters will fail to retain their shape during use, causing procedure delays and creating the risk of an adverse outcome. The FDA first warned users about the issue back in August.

"If you're not using an intravascular imaging modality, the PCI is not optimal," explained Haroon Faraz, MD, from Hackensack University Medical Center. Faraz is hopeful new and improved technologies will help these modalities become more popular among interventional cardiologists.

The Volt Pulsed Field Ablation System from Abbott has been approved by the FDA. The technology, which gained CE mark approval in March, features a one-of-a-kind catheter design and allows patients to be treated under conscious sedation.

Make way for MiniMed! Medtronic's diabetes division has filed the necessary paperwork to go public. The company hopes to be traded on Nasdaq under the symbol MMED.

AstraZeneca has stopped selling Andexxa because randomized data suggested some patients may face an increased risk of certain adverse events. The company emphasized that it remains confident in the agent's abilities.

A variety of CPT code changes take effect in 2026, and many of them will make a direct impact on interventional cardiology. Arnold Seto, MD, spoke to Cardiovascular Business about these updates for a new video interview.

New two-year data confirm that the IVL technology developed by Shockwave Medical can be used to treat diabetic patients who require PCI.

Mitral valve surgery can be especially challenging when patients present with a small mitral valve area. When it comes to M-TEER, however, treatment still appears to be both safe and effective.

The group was recently asked to provide input on a new set of recommendations for image-guided biopsies of suspicious breast lesions—offering providers clarity on key clinical scenarios.

Sean Clifford filed the lawsuit Sept. 24, 2024, in the New York State Supreme Court, contending a radiologist failed to spot signs of a forthcoming stroke.