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Terminated

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

FDA Recall Z-2194-2012 · Posted 2012-08-12

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDQO
Date Initiated2012-05-11
Date Terminated2014-06-17
Product Quantity32,145 units for all products in Recall Event

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.

Firm Action

Edwards Lifesciences sent a "PRODUCT RECALL" letter dated May 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Confirmation Form was attached for customers to complete and return via fax to 1-800-422-9329. Contact Customer Service at 1-800-424-3278 for questions regarding this notice.

Root Cause

Process control

Distribution Pattern

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).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHBaxter Healthcare Corp · 1992-09-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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