Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use Recalled by Edwards Lifesciences, LLC Due to The device is being recalled because the firm...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edwards Lifesciences, LLC directly.
Affected Products
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
Quantity: 32,145 units for all products in Recall Event
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Edwards Lifesciences, LLC
Edwards Lifesciences, LLC has 94 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report