Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Irvine, Calif.-based company’s Swan-Ganz Thermodilution catheters function as a diagnostic tool to determine hemodynamic pressures and cardiac output and are intended for use with a compatible cardiac output computer.
The catheters have indications for measuring hemodynamic conditions through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions, according to an FDA release. The distal port also allows for sampling of mixed venous blood for assessing oxygen transport balance and calculating derived parameters including oxygen consumption, oxygen utilization coefficient and intrapulmonary shunt fraction, according to the release.
A total of 875 devices are being recalled due to a non-conformance issue involving catheters with incorrect lumen assemblies which can cause reversal of the lumens. If lumens are reversed, a clinician may note PA and CVP pressure values and waveforms in reverse, according to the FDA release.
Edwards has reportedly been in contact with customers about the issue since December 21, 2018, according to the release.
Last week, Edwards Lifesciences posted fourth quarter and full year 2018 earnings that topped earnings per share consensus on Wall Street, but missed on full-year sales expectations.