FDA approves new Cardiovascular Systems saline pump after recall

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Cardiovascular SystemsCardiovascular Systems (NSDQ:CSII) said yesterday that it plans to have a saline infusion pump on the market this summer to replace the pump it recalled last month, now that the FDA granted pre-market approval for the new pump.

The pumps are used to provide saline and lubricant during orbital atherectomies with CSI’s Diamondback 360 device. The St. Paul, Minn.-based company pulled roughly 900 of the pumps April 17 after finding that electromagnetic interference in hospitals can cause them to switch to standby mode. There were no reports of patient injury, CSI said, and customers can continue to use the older models until the newer versions are available.

“The company anticipates replacing all recalled units by no later than August 31, 2017,” CSI said.

The pumps were sold between April 7, 2015 and April 4 of this year. The recall is expected to deliver a $1.5 million charge during CSI’s fiscal 3rd quarter.

Yesterday the company met expectations on Wall Street with its 3rd quarter results, posting losses of $1.7 million, or 5¢ per share, on sales of $52.1 million. CEO Scott Ward said the recall is likely to be “moderately disruptive” during the fiscal 4th quarter, when the CSI expects to report net losses of -6¢ to -4¢ per share on sales of $51.5 million to $52.5 million.

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