Recall Z-2198-2012 — Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
U.S. FDA — Device Enforcement · United States · 2012-05-11 · Class II
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Reported risk: 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.
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