Heart Surgery
FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs
Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…
LivaNova receives FDA 510(k) approval for new in-line blood monitor
Editor's Note The Essenz™ In-Line Blood Monitor (ILBM) has received U.S. FDA 510(k) clearance and CE mark, as announced by manufacturer LivaNova on August 30. The new ILBM provides “accurate and continuous measurement of essential blood parameters for perfusionists throughout cardiopulmonary bypass procedures,” and integrates with the company’s Essenz Perfusion…
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…
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