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Edwards Lifesciences, LLC recalls Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for
Recalled June 10, 2015 · FDA recall Z-1700-2015 · Edwards Lifesciences
Hazard
The product failed to meet the internal established statistical test requirement for heparin activity. · FDA Class II
Units
978
Sold at
Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
Description
The product failed to meet the internal established statistical test requirement for heparin activity.
Product
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.
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →