Cardiovascular Systems voluntarily recalled its 7-10014 saline infusion pumps, according to a company news release on April 17.
The pumps are used to provide saline and lubricant infusion during orbital atherectomy procedures and electrical power to the orbital atherectomy device.
Cardiovascular Systems said hospitals’ electromagnetic interference could cause the pumps to switch to the standby mode during use. If that occurs, operators must reset the pump, which can lead to delays in the orbital atherectomy procedure and potential injury risks.
The company said it had not received reports of any patient injuries, but it plans on recalling and replacing approximately 900 units. The recalled pumps were distributed between April 7, 2015, and April 4, 2017.
Cardiovascular Systems said it expected to record approximately $1.5 million of expenses due to the recall during the third quarter of fiscal year 2017. However, the company does not anticipate the charge having an adverse effect on its revenue.
The FDA has approved Cardiovascular System’s orbital atherectomy system in peripheral and coronary arteries. The company has sold more than 290,000 devices in the U.S.
In June 2016, Cardiovascular Systems agreed to pay $8 million to settle allegations that the company paid kickbacks to physicians to convince them to use its medical devices. The company paid $3 million in July and agreed to pay the remaining money in 11 quarterly installments that began in January.