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U.S. Department of Health and Human Services

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Edwards Lifesciences Aquarius Hemodialysis System: Recall

Audience: Nephrology and hemodialysis healthcare professionals, hospital risk managers

[Posted 02/03/2010] FDA notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System, Model number GEF09800, because of reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected, the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. It is possible to remove too much fluid from or replace too much fluid to the patient. In repeated cases, this imbalance increases, and may result in serious injuries or death. Baxter International, Inc. is the U.S. distributor of the Aquarius system. 

The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.

[02/03/2010 - Recall Notice - FDA]