The Saline Infusion Pumps provide saline and lubricant infusion during orbital atherectomy procedures and electrical power to the orbital atherectomy device. CSI 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 prior to 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. However, there have been no reports of patient injury to date.
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. CSI expects to record approximately $1.5 million of expenses in its third quarter of fiscal 2017 related to the recall and replacement of all affected Saline Infusion Pumps. The recall and related charge do not have an adverse effect on third quarter revenue and net loss guidance provided by the company on January 25, 2017. The company will provide additional financial updates during its regularly scheduled third quarter earnings conference call on May 3, 2017.