Recall Z-1310-06 ยท DYG Catheter, Flow Directed
Edwards Lifesciences Llc
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.
| Date | Aug 2, 2006 (initiated Jun 21, 2006) |
| Status | Terminated |
| Reason | 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 | 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 w |
| Quantity | 8305 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902628 | INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT Biometric Research Institute, Inc., Feb 25, 1991 |
| K924452 | SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER Baxter Healthcare Corp, Oct 29, 1993 |
| K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER Baxter Edwards, May 24, 1994 |
| K955816 | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR Baxter Healthcare Corp, May 6, 1997 |