Class 2 Device Recall VIGILANCE MONITOR

• Date Initiated by Firm: June 21, 2006
• Date Posted: August 02, 2006
• Recall Status: Terminated on August 07, 2008
• Recall Number: Z-1310-06
• Recall Event ID: 35777
• 510(K)Number: K902628 K924452 K940795 K955816
• Product Classification: cardiac output monitor - Product Code DYG
• Product: EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software release 5.3 or earlier only. Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM.
• Code Information: Lot Numbers: All devices serialized with software release 5.3 or earlier.
• Recalling Firm/ Manufacturer: Edwards Lifesciences Llc; One Edwards Way; Irvine CA 92614-5688
• For Additional Information Contact: John McGrath, PhD; 949-250-2515
• Manufacturer Reason for Recall: Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in overheating and thermal damage to the CCO catheter and serious patient injury.
• FDA Determined Cause: Other
• Action: Strategy to contact affected physicians accounts: Edwards will communicate to all accounts with affected monitors using distribution and sales records to identify those accounts. Letter dated 07/07/2006. In addition Edwards will analyze all CCO catheter sales and identify all accounts not on the monitor distribution list and include those accounts on the communication listing. Communication will be send via FedEx to the Risk Manager at each account with sufficient copies for the Heads of Departments of Surgery, Anesthesia, ICU, Nursing, Risk Management and Biomedical Engineering. Edwards will follow up by phone with each account that does not initiate contact per the Recall Letter. Edwards will make three attempts to contact the account by phone and complete the recall process.
• Quantity in Commerce: 8305
• Distribution: Worldwide
• 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 = DYG; 510(K)s with Product Code = DYG; 510(K)s with Product Code = DYG