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Cook Medical endovascular grafts recalled due to risk of coating breaking off, entering patient’s bloodstream.

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

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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.

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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.

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

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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.   

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This utilization management tactic disproportionately affects specialties such as diagnostic radiology, radiation oncology and cardiology. 

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As IR procedure volumes continue to climb, coupled with anesthesiology provider shortages, there is growing interest in achieving “deeper, more reliable sedation.” 

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A new analysis claims the “benchmark” qualifying payment amount insurers calculate often “dramatically” understates the actual median in-network rates they are paying for in-network care.  

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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.

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The software has been primarily disguised as Philips’ DICOM MediaViewerLauncher.exe—a trusted program that enables patients to view their medical imaging on their own personal servers. 

Lisa Carter-Bawa, PhD, MPH

Those involved plan to hire a community health worker and care navigator to help shepherd underserved patients through the screening process. 

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