Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
Reported: August 22, 2012 Initiated: May 11, 2012 #Z-2190-2012
Product Description
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. 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.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 32,145 units for all products in Recall Event
- Distribution
- 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).
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.. Recalled by Edwards Lifesciences, LLC. Units affected: 32,145 units for all products in Recall Event.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2012. Severity: Moderate. Recall number: Z-2190-2012.
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