Food and Drug Administration Malfunction Recalls of Left Ventricular Assist Devices. Issue 7 (July 2020)

• Record Type: Journal Article
• Authors: Lugo Baruqui, Diego; Maning, Jennifer; Chaparro, Sandra V.
• Is Part Of: ASAIO journal. Volume 66:Issue 7(2020)
• Publication Date: 2020-07
• Subjects: malfunction -- LVAD -- FDA recall -- left ventricular assist device -- left ventricular assist system -- HeartWare -- HeartMate II -- HeartMate 3 -- total artificial heart; Artificial organs -- Periodicals; 617
• DOI: 10.1097/MAT.0000000000001118
• Languages: English
• ISSNs: 1058-2916

Abstract

Abstract : Left ventricular assist devices (LVADs) are being increasingly implanted given the increasing prevalence of patients with advanced heart failure stages. However, they are not exempt from device malfunctions. A PubMed search for the key words (left ventricular assist device malfunction) (ventricular assist system malfunction) was performed. We identified 28 publications in the US Food and Drug Administration (FDA) website database that addressed LVAD malfunction. Twenty-nine FDA recalls were identified regarding LVAD malfunctions: 17 regarding HeartWare ventricular assist device, six for HeartMate II, three for HeartMate 3, and three for total artificial heart. Mechanisms involved in LVAD malfunction include battery malfunction, loose driveline connector, malfunction of the system controller, loose power supply connector ports, malfunction of the driveline splice kit, problems with the percutaneous lead connection, disconnection of the bend relief and outflow graft and outflow graft occlusion among others. Multiple mechanisms could be linked to LVAD malfunction. However, multiple device modifications have been developed over the past decade to avoid recurrent malfunctions. Constant improvements and research in biotechnology are needed to prevent these complications. It remains to be seen if newer generation devices will lead to improved patient outcomes over the long term. Abstract : Supplemental Digital Content is available in the text.