Editor's Note The Food and Drug Administration (FDA), on April 26, identified the recall by Cordis Corporation of its Precise PRO Rx US Carotid System as Class I, the most serious. The Carotid System is being recalled due to a risk of separation of the atraumatic distal tip of the…

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Editor's Note The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), on April 23, announced that after a thorough safety review, the pause on the Janssen/Johnson & Johnson (J&J) COVID-19 vaccine should be lifted, and use of the vaccine should resume. The pause was…

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Editor's Note The Food and Drug Administration (FDA), on April 20, identified the recall of Medtronic’s Bio-Console 560 Extracorporeal Blood Pumping Console as Class I, the most serious. The Console is used during heart surgery to pump and return blood to a patient during cardiopulmonary bypass. The recall was initiated…

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Editor's Note The Food and Drug Administration (FDA), on April 12, identified the recall of Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of an unexpected and rapid…

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Editor's Note The Food and Drug Administration (FDA), on April 9, sent a letter to healthcare providers recommending they “transition away from crisis capacity conservation strategies,” including disinfection and reuse of N95 masks. Though the FDA believes there is an adequate supply of N95s now to facilitate this transition, the…

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Editor's Note In this study from the University of Denver and the University of Pennsylvania, Philadelphia, respondents to two surveys agreed with the National Academies of Science, Engineering, and Medicine’s prioritization framework for COVID-19 vaccination. Of 4,735 respondents (2,730 to a Gallup survey and 2,005 to a COVID Collaborative survey):…

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Editor's Note The Food & Drug Administration (FDA), on April 9, identified the recall of Medtronic’s Valiant Navion Thoracic Stent Graft System as Class I, the most serious. The recall was initiated because of the risk of stent fractures and endoleak concerns. The system is used to repair lesions of…

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Editor's Note The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious. The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device…

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Editor's Note This survey by researchers at the Geisinger Health System, Danville, Pennsylvania, shows a trend of increased intention by healthcare workers to receive a COVID-19 vaccine. A total of 16,292 employees completed the survey, for a response rate of 68.5%. During the period of survey data collection, the researchers…

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Editor's Note The Food and Drug Administration (FDA), on March 17, identified the recall by ACIST of its Kodama Intravascular Ultrasound Catheter as Class I, the most serious. The recall was initiated because the O-ring housing tubing may squeeze and damage the O-ring. If there is damage, broken O-ring pieces…

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