Heart Surgery
FDA: Class I recall of labeling for Impella RP Flex with SmartAssist
Editor's Note The Food and Drug Administration (FDA), on August 17, identified the recall by Abiomed of the labeling for its Impella RP Flex with Smart Assist System Catheter as Class I, the most serious. The recall was initiated because the catheters’ instructions for use did not appropriately address precautions…
Study: Surgeon communication with patients on innovative procedures
Editor's Note This study from the UK finds that patients are not given sufficient information about innovative surgical procedures and their potential risks and uncertainties. Researchers collected data on seven cases, using preoperative interviews with surgeons, audio-recorded consultations during which innovative procedures were discussed between surgeons and patients, and postoperative…
Effect of poverty on surgical care, postop outcomes
Editor's Note This study from the Ohio State University Wexner Medical Center, Columbus, examines the association between long-standing poverty and postoperative outcomes. The analysis included 335, 595 patients who underwent lung resection, colectomy, coronary artery bypass grafting, or lower extremity joint replacement, and who were categorized according to the duration…
FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs
Editor's Note The Food and Drug Administration (FDA), on August 10, identified the recall by Datascope/Maquet/Getinge of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because the pumps may shut down unexpectedly due to electrical failures in the Power…
FDA: Class I recall of GE HealthCare’s TruSignal SpO2 sensors
Editor's Note The Food and Drug Administration (FDA), on July 28, identified the recall by GE HealthCare of its TruSignal SpO2 [arterial oxygen saturation] sensors as Class I, the most serious. The recall was initiated because of issues that may reduce the amount of energy sent to the heart during…
FDA: Class I recall of Abiomed Impella Left Sided Blood Pumps
Editor's Note The Food and Drug Administration (FDA), on July 27, identified the recall by Abiomed of all Impella Left Sided Blood Pumps as Class I, the most serious. Abiomed is recalling the pumps because the instructions for use do not adequately address precautions to take when treating transcatheter aortic…
FDA: Class I recall of Abbott Amplatzer Steerable Delivery Sheath
Editor's Note The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious. Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures…
Does a ‘weekend warrior’ physical activity pattern prevent cardiovascular disease?
Editor's Note This study by researches at the Massachusetts General Hospital, Boston, and the Broad Institute of MIT and Harvard, Cambridge, Massachusetts, examines whether moderate to vigorous physical activity concentrated in 1 to 2 days of the week (ie, a “weekend warrior” pattern) confers similar cardiovascular benefits as more evenly…
FDA: Class I recall of Quidel Triage Cardiac Panels
Editor's Note The Food and Drug Administration (FDA), on July 17, identified the recall by Quidel Cardiovascular Inc of its Quidel Triage Cardiac Panels as Class I, the most serious. The recall was initiated because of reports of inaccurate tests showing lower than expected troponin levels in samples. A falsely…
Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices
Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…
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