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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Edwards Lifesciences, LLC: 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.

Agency Publication Date: August 12, 2012
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Affected Products

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.

59243259, 59263146

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.

59194311, 59194312, 59194313, 59197002, 59197003, 59197893, 59197894, 59197895, 59197896, 59203369, 59203370, 59203371, 59203372, 59203373, 59219841, 59219842, 59219844, 59219845, 59224417, 59247409, 59247410, 59247411, 59247413

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.

59174383, 59174384, 59216111, 59219855, 59233891, 59247471, 59252542

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.

59169527, 59169528, 59174318, 59174320, 59194314, 59194315, 59194316, 59194317, 59197004, 59197005, 59197006, 59197007, 59197008, 59197009, 59197010, 59197897, 59197898, 59197899, 59197900, 59197901, 59197902, 59197903, 59203374. 59203375, 59203377, 59203378, 59203379, 59203380, 59203381, 59207074, 59207075, 59207076, 59207077, 59216092, 59216093, 59216094, 59216096, 59216097, 59216098, 59216099, 59219846, 59230687, 59230688, 59230689, 59230690, 59230691, 59230692, 59233882, 59238962, 59238963, 59238964, 59238965, 59243250, 59243249, 59247419, 59247421, 59247420, 59247422, 59247423, 59247424, 59247425, 59247426, 59247427, 59247428, 59247429

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.

59197000, 59197001, 59216091, 59218827, 59238961

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.

59194300, 59203362, 59216087, 59233785, 59243242

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

59194334, 59224788, 59239507, 59247472

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.

59174297, 59194298, 59194299, 59197887, 59203360, 59203361, 59207070, 59219837, 59247401, 59247402

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

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

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.

59163071, 59174300, 59178366, 59233787

Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.

59267057

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 62278
Status: Resolved
Manufacturer: Edwards Lifesciences, LLC
Manufactured In: United States
Units Affected: 11 products (32,145 units for all products in Recall Event)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.