Cardiovascular Systems (NSDQ:CSII) launched a voluntary recall yesterday of its 7-10014 saline infusion pump, telling customers that they can continue to use the device until they receive a replacement.
The pumps provide saline and lubricant infusion during orbital atherectomy procedures and electrical power to the orbital atherectomay device. The company found that electromagnetic interference from the hospital environment can cause the pumps to switch to standby mode during use, at which time the pump must be reset before continuing treatment.
Restarting the saline infusion pump can delay a orbital atherectomy procedure, the company said, and adds additional risk to patients undergoing coronary artery procedures. Cardiovascular Systems added that, to date, it has not received any reports of patient injury.
The 900 recalled pumps were distributed between April 7, 2015 and April 4, 2017. Cardiovascular Systems reported that it plans to record about $1.5 million in expenses in the 3rd quarter of fiscal 2017 related to the recall. However, the company added that it doesn’t expect the charge to have an adverse effect on 3rd quarter revenue and net loss guidance.
Earlier this month, Cardiovascular Systems closed the sale of its St. Paul, Minn.-based headquarters to Krishna Holdings for $21.5 million and inked a revolving credit facility with Silicon Valley Bank.