The Food and Drug Administration (FDA) has announced
a Class 1 recall of certain Swan-Ganz Thermodilution Catheters manufactured by Edwards Lifesciences in Irvine, Calif.
The catheters were incorrectly assembled, which could result in serious adverse health consequences or death of patients, the FDA states.
Specifically, the catheters were incorrectly assembled so that the catheter tubes, or lumens, were reversed. According to FDA, that means “the clinician may note inaccurate pulmonary artery and central venous pressure values and waveforms. This may result in unintended treatment, which may result in adverse health consequences.
In addition, “the inaccurate waveforms and pressure values may also misguide a physician during placement of the catheter, increasing the risk of blood vessel perforation. This exposes the patient to a reasonable likelihood of a serious adverse health consequence or death,” FDA stated in the recall notice.
Swan-Ganz catheters affected by the recall include those manufactured by Edwards Lifesciences under the model numbers 131F7, 131F7J, 131F7P, 131VF7P, 151F7 between Dec. 26, 2017, and April 19, 2018.
Edwards Lifesciences sent an “Urgent Recall Notification Letter” to affected customers on Dec. 12, according to FDA. Customers with questions may contact the company at: 1-(800)-822-9837, option 1.
Find out more about the recall
here.