FDA Proposes Updates To Peripheral Vascular Atherectomy Devices Guidance
US regulators are proposing updates to a guidance document they finalized in February for devices used to clear arteries of plaque. The updated language specifically addresses software interoperability, pyrogenicity and certain performance-testing requirements.
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The US agency has finalized an update to a previous guidance on devices used to remove atherosclerotic plaque that addresses new software, pyrogenicity and testing concerns.
US regulators have announced a second serious recall for a faulty catheter in the past month. The problem with Vascular Solutions’ catheter seems to be similar to Boston Scientific’s recall earlier this month, where a part of the device may break off and get stuck in the patient.
Boston Scientific has recalled more than 6,000 angiographic catheters because the tip can fall off and get stuck in patients, potentially causing serious injury or death. The company says customers should immediately stop using the lots associated with the faulty products and return them.