Edwards Lifesciences, LLC recalls Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for…

Recall date

May 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1700-2015

FDA classification

Class II

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)

Why it was recalled

The product failed to meet the internal established statistical test requirement for heparin activity.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.