Recall Z-2194-2012— Edwards Lifesciences, LLC

Name: FDA recall Z-2194-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-11

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2012-05-11, terminated 2014-06-17. It names one FDA 510(k) clearance: K915726. Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.. Reason: 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..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-05-11
Terminated: 2014-06-17
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K915726 — PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHBaxter Healthcare Corp·cleared 1992-09-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.