Z-1310-06

EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software release 5.3 or earlier only...

Name: Z-1310-06 EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software release 5.3 or earlier only...
Creator: Edwards Lifesciences Llc
Published: 2006-06-21
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2006-06-21 / Terminated / root cause: software

FDA source

Edwards Lifesciences Llc began a recall of EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software release 5.3 or earlier only. Patient monitor which measures cardiac output... on 2006-06-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1310-06
Status: Terminated
Initiated: 2006-06-21
Posted: 2006-08-02
Terminated: 2008-08-07
Recalling firm: Edwards Lifesciences LLC
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.
Product code: DYG Catheter, Flow Directed
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.
Root cause tag: software
FDA root 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
Product codes and lots: Lot Numbers: All devices serialized with software release 5.3 or earlier.

Product code DYG

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)