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Medical Perfusion
Industry News

FDA Advises Healthcare Facilities to Transition Away from Getinge’s Heart Devices Due to Safety Concerns

The U.S. Food and Drug Administration (FDA) has issued a recommendation urging healthcare facilities to discontinue the use of Getinge’s heart devices, including the Cardiohelp system and HLS Sets, as well as the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. This advisory comes in response to ongoing safety and quality concerns despite multiple…


FDA Approves Two Gene Therapies for Sickle Cell Disease

The U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for treating sickle cell disease (SCD) in patients 12 years and older.Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. It is most common in African Americans and,…


Abiomed Recalls Impella Left Sided Blood Pumps

The US Food and Drug Administration (FDA) has announced a Class 1 recall of all Impella left-sided blood pumps. “There is a potential risk that the Impella motor housing may come into contact with the distal stent of a transcatheter aortic valve replacement (TAVR),” the FDA’s announcement says. “The contact may damage or destroy the…


FDA Approves First Leadless Dual-Chamber Pacing System by Abbott

The FDA has approved Abbott’s AVEIR dual chamber (DR) leadless pacemaker system. The AVEIR DR leadless pacing system is made up of two devices: the previously approved AVEIR VR single chamber device, which paces the right ventricle, and the now-approved AVEIR AR single chamber device, which paces the right atrium. “Leadless pacemakers have been limited…


FDA Recall for Arrow International, LLC, a subsidiary of Teleflex, Inc

Arrow International, LLC, a subsidiary of Teleflex, Inc, is recalling Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps after receiving complaints that battery power is not lasting as expected. The FDA has identified this as a Class I recall. A fully charged battery should last 90 minutes; however, multiple users report the devices are experiencing…


LivaNova (TandemLife) Recalls LifeSPARC System

LivaNova (TandemLife) has recalled the LifeSPARC controller, part of the LifeSPARC system, because of a software malfunction that may cause the controller’s monitoring feature to wrongly enter critical failure mode, causing the pump to stop working. The FDA has identified this as a Class I recall. To date, LivaNova has received 66 complaints about the…


FDA recall for The HeartWare Ventricular Assist Device (HVAD) by Medtronic, Inc.

The FDA has identified this as a Class I recall for The HeartWare Ventricular Assist Device (HVAD) by Medtronic, Inc., the recall is due to welding defects that allow separation of the two cell battery packs used to power the system. The welding defect may cause the battery to malfunction and no longer provide power…


FDA announces Class I recall of Cardiosave intra-aortic balloon pumps (IABPs)

The FDA, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. Getinge/Datascope/Maquet is recalling these products due to complaints of fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy.There has…


GE Healthcare Receives FDA Clearance for First Artificial Intelligence (AI) Algorithm

GE Healthcare today announced it has received Food and Drug Administration (FDA) approval for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for…


FDA announces Class I recall of battery packs for intra-aortic balloon pumps

The FDA has identified this as a Class I recall on Datascope/Getinge/Maquet for Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs due to the risk of the battery failing and having a shortened run-time due to substandard batteries not meeting performance specifications being released to customers, which may cause the device to stop working when operated…


FDA approves TransMedics’ OCS Heart system

TransMedics Group has secured approval from the US Food and Drug Administration (FDA) for its OCS Heart System that is developed for use with organs collected from donors after brain death (DBD). The OCS Heart System is designed to preserve DBD donor hearts deemed unsuitable for procurement and transplantation at initial assessment due to limitations…


FDA Approves Abbott’s Portico Valve for TAVR

The US Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with “symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery,” the company announced recently. Portico is a self-expanding TAVR valve with leaflets that help provide optimal blood flow when…


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