LLC Edwards Life Sciences

Recipient:Edwards Life Sciences, LLC
Product: Swan-Ganz Continuous Cardiac Output (CCO) Catheter, Vigilance Monitors, and stents

Failure to submit a supplemental report to FDA within 1 month of receipt of information that was known to you regarding a serious injury reportable under 21 CFR 803.50, as required by 21 CFR 803.56. For example,
b) A similar complaint from [redacted] for a CCO catheter that had melted during a procedure on October 9, 2002, was not disclosed in a supplemental report although your firm was aware that a software problem was the root cause of the event.

FDA District: Los Angeles District Office

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

Partners located in the US (CA, FL, MA, MN, TN) and Italy.