Heart Surgery
FDA: Class I recall of Datascope/Getinge Cardiosave Hybrid, Rescue IABPs
Editor's Note The Food and Drug Administration (FDA) on January 25 identified the recall by Datascope/Gettinge of its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the risk that blood may enter the pump through a damaged balloon…
FDA: Class I recall of Arrow AutoCAT2, AC3 IABPs
Editor's Note The Food and Drug Administration (FDA), on December 20, identified the recall by Arrow International, LLC, subsidiary of Teleflex, Inc, of its Arrow AutoCAT 2 and AC3 intra-aortic balloon pumps (IABPs) as Class I, the most serious. IABPs are used in patients having cardiac and non-cardiac surgery, and…
Study: Better OR ventilation linked to lower SSI rates
Editor's Note This Swiss study finds that better OR ventilation properties, as assessed with a new ventilation index, are associated with lower rates of surgical site infections (SSIs) in orthopedic, spine, and cardiac procedures. Researchers calculated a ventilation index with higher values reflecting less turbulent air displacement instead of comparing…
FDA: Class I recall of LivaNova’s LifeSPARC System
Editor's Note The Food and Drug Administration (FDA) on September 30 identified the recall by LivaNova (TandemLife) of its LifeSPARC System, Model LS-1000, as Class I, the most serious. The recall was initiated because of the risk of unintentional extended pump stop during Controller Critical Failure mode, caused by a…
FDA: Class I recall of Medtronic’s HeartWare HVAD system batteries
Editor's Note The Food and Drug Administration on August 25 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system batteries as Class I, the most serious. Medtronic is recalling the batteries because they may experience electrical faults that cause them to unexpectedly fail. A similar recall…
FDA: Class I recall of Medtronic’s HVAD batteries
Editor's Note The Food and Drug Administration (FDA), on June 23, identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) batteries as Class I, the most serious. The recall for a single lot (Model Number:1650DE) of HVAD batteries was initiated because of welding defects that allow separation…
FDA: Class I recall of Medtronic HVAD Pump Implant Kit
Editor's Note The Food and Drug Administration (FDA) on June 8 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit as Class I, the most serious. The HVAD System is used as a bridge to cardiac transplants. The Kit was recalled because of a…
Collateral damage of COVID-19 on CV services
Editor's Note This systematic review and meta-analysis led by researchers in the UK finds that across the world, cardiovascular (CV) services were severely disrupted, and as a result cardiac disease is expected to worsen, and repercussions will be felt for years to come. This analysis spans 2 years (2020 to…
UW Medicine conducting national clinical trial on inflatable tubular stent
Editor's Note Cardiologists at the University of Washington School of Medicine (UW Medicine) in Seattle, Washington, are participating in a national clinical trial to test a device designed to control bleeding if a vessel near the heart is inadvertently perforated during a catheter-based procedure, Healthcare Purchasing News May 26 reported.…
The Joint Commission, AHA launch Comprehensive Heart Attack Center certification program
Editor's Note The Joint Commission and the American Heart Association, on April 20, announced the launch of a Comprehensive Heart Attack Center certification program, which recognizes hospitals providing care to the most complex and critically ill patients. To be certified, hospitals must provide 24-hours-a-day, 7-days-a-week on-site coverage for primary percutaneous…
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