Z-0653-2010

Edwards Lifesciences Aquarius System Model GEF09800

Name: Z-0653-2010 Edwards Lifesciences Aquarius System Model GEF09800
Creator: Edwards Lifesciences, Llc
Published: 2009-03-16
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2009-03-16 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, Llc began a recall of Edwards Lifesciences Aquarius System Model GEF09800 on 2009-03-16. The reason FDA records is "There have been 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0653-2010
Status: Terminated
Initiated: 2009-03-16
Posted: 2010-01-27
Terminated: 2012-01-18
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences Aquarius System Model GEF09800.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: There have been 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 extreme cases, this may result in serious injuries or death.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Edwards is continuing a field corrective action related to the possibility of fluid imbalance when using the Aquarius. In order to mitigate some of the risk associated with this problem, Edwards sent notifications to consignees advising of mitigation steps. Consignees were provided: a description of the affected product, problem, and potential hazard; advice on action to be taken; and revised device labeling. Additionally, consignees were notified of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period. Although Edwards does not believe there is a need to stop using the Aquarius system at this time, clinicians should weigh the risks/benefits to the patients before continuing the use of the device Edwards first provided some of this information to consignees in a Field Safety Notice on March 16, 2009. On January 11, 2010, Edwards provided an Urgent Product Recall letter to consignees which updated and expanded the earlier communication. The FDA classified this as a Class I recall.
Quantity in commerce: 135 units
Distribution: Nationwide Distribution.
Product codes and lots: Model GEF09800 all units/serial numbers.

Product code KDI

K070320Class IIEdwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH / cleared 2007-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)