CSI Initiates Voluntary Recall of Saline Infusion Pump


April 20, 2017—Cardiovascular Systems, Inc. (CSI) announced that it has initiated a voluntary recall of its 7-10014 saline infusion pump, which provides saline and lubricant infusion during orbital atherectomy procedures and electrical power for the company's orbital atherectomy device.

CSI initiated a customer communication of the recall by letter and informed customers that they may continue to use the affected saline infusion pumps until they receive a replacement. The pumps included in the recall were distributed between April 7, 2015 and April 4, 2017. The company plans to recall and replace approximately 900 units currently in customer inventory.

The company stated that is has determined that electromagnetic interference present in the hospital environment may cause the pumps to switch to standby mode during use, requiring the pump to be reset before continuing treatment. Restoring pump operation can result in a temporary delay in the orbital atherectomy procedure.

In coronary artery procedures, this delay of therapy could present an additional risk of a temporary, medically reversible injury. There have been no reports of patient injury to date, advised CSI.


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.