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the words "FDA recall" on a board

While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately. 

The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA

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.

Cardiologists employed by a hospital appear to be more likely to pursue cardiac catheterization or angioplasty than independent cardiologists. female physician male

The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting. 

patient undergoing CCTA exam

The rapid rise of CCTA represents one of cardiology’s biggest ongoing trends, but most primary care providers are still not embracing a CT-first strategy.

Federal Trade Comission FTC Sign logo

The merger between Aya Healthcare and Cross Country Healthcare was finalized in December 2024 and was expected to close in the first half of this year. It's unclear what information the Federal Trade Commission requested from both companies. 

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More than 33,000 devices are affected by this recall. Customers may need to return and replace the purge cassettes included with their devices due to a risk of serious injury or death.