Class 1 Device Recall EDWARDS AQUARIUS HEMOFILTRATION SYSTEM

• Date Initiated by Firm: March 16, 2009
• Date Posted: January 27, 2010
• Recall Status: Terminated on January 18, 2012
• Recall Number: Z-0653-2010
• Recall Event ID: 53554
• 510(K)Number: K070320
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Edwards Lifesciences Aquarius System Model GEF09800.
• Code Information: Model GEF09800 all units/serial numbers.
• FEI Number: 2015691
• Recalling Firm/ Manufacturer: Edwards Lifesciences, Llc; 1 Edwards Way; Irvine CA 92614-5688
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KDI