Swan-Ganz thermodilution catheters manufactured between December 26, 2017, and April 19, 2018, are being recalled by Edwards Lifesciences, according to the US Food and Drug Administration (FDA).
The class I recall is being initiated because of incorrect assembly leading to catheter tube (lumens) reversal. If the lumens are reversed, inaccurate pulmonary artery and central venous pressure values and waveforms may result, leading to unintended treatment.
The FDA added that the inaccurate values and waveforms may misguide a physician while placing the catheter, which could increase the risk for blood vessel perforation. This could expose the patient to “a reasonable likelihood of a serious health consequence or death.”
The following model and lot numbers, distributed between January 20 and August 20, 2019, are affected by the recall:
- Model numbers: 131F7, 131F7J, 131F7P, 131VF7P, and 151F7
- Lot numbers: 61321177, 61176373, 61227528, 61321254, 61176369, 61176314, 61176370, 61176367, 61176374, 61321241, and 6131158
Edwards Lifesciences is urging that unused units with the affected model and lot numbers be returned for replacement at no charge.
A class I recall is the most serious type of recall identified by the FDA, as use of the affected device may cause serious injury or death.
For more information about this recall or to report a problem, please visit the dedicated recall page on the FDA website.
Edwards Lifesciences recalls Swan-Ganz thermodilution catheter due to incorrect assembly causing reversal of lumens [news release]. Silver Spring, MD: US Food and Drug Administration; February 5, 2019. https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm630774.htm. Accessed February 5, 2019.