Sep

2006

, Class II Edwards Lifesciences Llc

Company: Edwards Lifesciences Llc,
Date of Enforcement Report:8/23/2006
Class:ll

PRODUCT
Edwards Vigilance Monitors (Formerly Baxter Vigilance Monitors). Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM, Recall # Z-1310-06

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.

CODE
All devices serialized with software release 5.3 or earlier.

RECALLING FIRM/MANUFACTURER
Edwards Lifesciences Llc, Irvine, CA, by telephone and letter dated July 7, 2006. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
8,305 devices

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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, Class II Edwards Lifesciences Llc

Amy Sellers

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