Irvine-based Edwards Lifesciences Corp. is working with its former parent on the recall of a medical device that traded hands between the pair last year.
The Food and Drug Administration said Friday that it recalled the Aquarius Hemodialysis system, which is owned and distributed by Baxter International Inc.
Regulators said they issued a Class I recall, its most severe action, after reports of clinically significant fluid imbalance and the potential for patients to repeatedly override an imbalance alarm.
The FDA said that could result in serious injuries or death because of a decrease or increase in circulating blood.
Baxter, based in the Chicago area, said the recall affected fewer than 150 units, and that it would put in a software update to solve the problem at the end of the current quarter.
Edwards sold Aquarius and other devices that help patients with malfunctioning kidneys to Baxter last year for $65 million as part of Edwards’ focus on its mainstay heart valves.
A Baxter spokeswoman told Reuters that Edwards still has quality and regulatory responsibility for Aquarius and that it would work with Edwards on the recall. Baxter is bearing the cost of the recall.
Edwards isn’t aware of injuries or deaths related to the issue, a spokeswoman said.
The devices are used for a treatment called hemofiltration, which mimics kidney function 24 hours a day for patients who have life-threatening kidney injuries or fluid overload. Hemofiltration’s usually administered in intensive care settings in the hospital.
Edwards, which has sales of more than $1 billion, spun off from Baxter in 2000 and is primarily known as a maker of replacement heart valves and other cardiovascular devices.
