Retiro De Equipo (Recall) de Device Recall VIGILANCE MONITOR

Recall

35777

Class 2

Z-1310-06

2006-06-21

2006-08-02

Terminated

United States

2008-08-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46857

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.

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.