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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.