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FDA, Edwards issue Class I recall of hemodialysis system

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The Food & Drug Administration and Edwards Lifesciences Inc. (NYSE:EW) issued a Class I recall of the Aquarius hemodialysis system after reports came in of "clinically significant fluid imbalance."

The device, used to remove waste products and extra fluid from the blood of patients with kidney failure, is designed to monitor the flow of fluid in and out of patients’ bodies and to trigger an alarm if it detects an imbalance. Patients can override the alarm without fixing the problem that caused it (a kink in the line, for example), causing an increase or decrease in patients’ blood volume.

Irvine, Calif.-based Edwards sent a letter to customers Jan. 11 advising them of the potential problem and the steps to take to correct it, including its plans to release a software upgrade to prevent patients from overriding the alarm more than five times within a 20-minute period.

A Class I recall is the highest level of callback and means the federal watchdog agency believes there’s a possibility the recalled device could cause serious injury or death. Edwards spokeswoman Amanda Fowler told MassDevice that no adverse effects were reported as a result of the potential problem as of March 2009 and said the company volunteered to upgrade the software then. That upgrade won 510(k) clearance from the FDA last November, Fowler said, but hasn’t yet been put in place.

The recall includes the following model numbers, distributed between July 12, 2007 and March 18, 2009, by Baxter International Inc. (NYSE:BAX): GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04.

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