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All product recalls associated with Edwards Lifesciences Llc One Edwards Way.
Total Recalls
2
Past Year
0
Class I (Serious)
0
Most Recent
Jun 2006
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
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.
Potential for deployment difficulties.