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April 20, 2017
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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