Background\nDue to an ageing population and demographic changes worldwide, a higher prevalence of\nheart disease is forecasted, which causes an even higher demand for cardiac implants in future.\nThe increasing high incidence of clinical adverse events attributed especially to highrisk\nmedical devices has led an advocated change from many stakeholders. This holds especially\ntrue for devices like cardiac implants, with their high-risk nature and high complication\nrates associated with considerable mortality, due to their frequent use in older\npopulations with frequent co-morbidities. To ensure patients� safety, the objective of this\nstudy is to analyze different cardiac implants recall reasons and different recall systems,\nbased on an overview of the recalls of cardiac implant medical devices in the last decade.\nOn the basis of the results from this structured analysis, this study provides recommendations\non how to avoid such recalls from a manufacturer perspective, as well as how to timely\nreact to an adverse event from a post-surveillance system perspective.\nMethods and Findings\nA systematic search of cardiac implant recalls information has been performed in the\nPubMed, ScienceDirect and Scopus databases, as well as data sources in regulatory authorities\nfrom 193 UN Member States. Data has been extracted for the years 2004-2014\nwith the following criteria applied: cardiac implant medical device recalls and reasons for recall,\nassociated harm or risk to patients. From the data sources described above, eleven\nregulatory authorities and 103 recall reports have been included in this study. The largest\ncardiac implant categories include ICDs 40.8%, pacemakers 14.5%and stents 14.5%. Regarding\nthe recall reasons, the majority of reports were related to device battery problems\n(33.0%) and incorrect therapy delivery (31.1%). From a total of 103 recall reports, five reported\ndeath and serious injuries. Our review highlights weaknesses in the current cardiac\nimplant recall system, including data reporting and management issues and provides recommendations\nfor the improvement of safety information and management.\nConclusion\nDue to the mortality associated with the nature of cardiac implants, the traceability and\ntransparency of safety hazards information is crucial. By a structured analysis of recall reasons\nand their efficient management, important knowledge is gained to inform an effective\nsafety-reporting system for monitoring the safety of cardiac implanted patients, ideally by\nbuilding up cardiac implant registries worldwide in the future.
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