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# Edwards Lifesciences Class 1 Recall of Catheters
- URL: https://www.fdaweb.com/edwards-lifesciences-class-1-recall-of-catheters/
- Published: 2019-02-05T12:00:00.000Z
- Updated: 2026-09-15T01:00:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143306

FDA has classified as Class 1 an Edwards Lifesciences recall of its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured between 12/26/2017 and 4/19/2018\. An [FDA notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm630774.htm?utm%5Fcampaign=FDA%20MedWatch%20Recall%20Notice%20-%20Swan-Ganz%20Thermodilution%20Catheter&utm%5Fmedium=email&utm%5Fsource=Eloqua) says the recall is due to incorrect assembly and reversal of the catheter tubes (lumens). “If the lumens are reversed, the clinician may note inaccurate pulmonary artery and central venous pressure values and waveforms,” the agency says. “This may result in unintended treatment, which may result in adverse health consequences.” Inaccurate waveforms and pressure values may also misguide a physician during catheter placement, increasing the risk of blood vessel perforation, it says.