New payment model on the way | Major recalls could impact care | Policy changes for breakthrough devices

Samuel Jones, MD, reviews some of the biggest concerns about a new Medicare payment model focused on heart failure care that goes live in 2027. 

This Class II recall includes more than 18,000 cannulae used during cardiac surgery.

CMS and the FDA say the goal is to improve patient access to medical devices that address an unmet need.

The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025. 

When CMS finalized coverage for cardiac ablations performed in ASCs, experts from HRS and ACC published recommendations for performing those procedures safely and effectively. One of the cardiologists behind that guidance shared some important takeaways with Cardiovascular Business. 

SCAI said reversing the processing hold allows physicians to continue serving patients and helps stabilize the workforce.

Stryker Sustainability Solutions is recalling more than 8,000 reprocessed medical devices. This is a Class II recall, according to the FDA, and these devices should no longer be used to treat patients.

The physician was accused of pressuring Medicare patients into undergoing treatment they did not need. One patient allegedly received 42 different stents over an eight-year period.

The new Class I recall, which includes more than 1.4 million devices, is related to an issue first announced back in 2024. Updating the software should address the issue going forward, though some patients may still require an early replacement.