🔍 RecallPedia

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.

Class I - Dangerous
🏥 Medical Devices Recalled: May 11, 2012 Edwards Lifesciences Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    59174304, 59174305, 59174306, 59196997, 59211405, 59211406, 59211407, 59211408, 59216088, 59233788, 59233789, 59253934, 59252521, 59252522, 59252523, 59252524
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Edwards Lifesciences, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.

Product Codes/Lot Numbers:

59174304, 59174305, 59174306, 59196997, 59211405, 59211406, 59211407, 59211408, 59216088, 59233788, 59233789, 59253934, 59252521, 59252522, 59252523, 59252524

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2196-2012

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Class I - Dangerous

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May 14, 2025 Other Medical Devices Nationwide View Details →