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Edwards Lifesciences, LLC recalls Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynam
Recalled August 22, 2012 · FDA recall Z-2198-2012 · Edwards Lifesciences
Hazard
The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. · FDA Class II
Units
32,145 units for all products in Recall Event
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).
Description
The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →