Home / Recalls / Medical Devices
Edwards Lifesciences, LLC recalls Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F
Recalled April 19, 2023 · FDA recall Z-1380-2023 · Edwards Lifesciences
Hazard
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message. · FDA Class II
Units
326 units
Sold at
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
Description
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
Product
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →