Edwards Lifesciences is recalling its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured Dec. 26, 2017, to April 19, 2018 due, to incorrect assembly that reversed the catheter lumens. This recall includes 1,426 devices in the United States.
If the lumens are reversed 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. The FDA recall notice stated 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, the FDA said.
These catheters provide a diagnostic tool for physicians to quickly measure blood pressures inside the veins, heart, and arteries and to measure blood flow and blood oxygen levels when used with a compatible cardiac output computer. These catheters are often used in patients who are undergoing complex surgery, such as open heart surgery, or require intensive, invasive monitoring to guide their care during serious illness.
Lot numbers included in this recall are: 61321177, 61176373, 61227528, 61321254, 61176369, 61176314, 61176370, 61176367, 61176374, 61321241 and 61311580.
On Dec. 12, 2018, Edwards Lifesciences sent affected customers an “Urgent Recall Notification Letter” informing of affected model/lot numbers. The notice requested that customers return any unused units that are currently in their inventory with the affected model and lot numbers. Once returned, replacement product will be shipped to customers at no charge. Edwards Lifesciences pre-populated a “Customer Acknowledgement” form, attached to the notification, with the affected lots and requested that customers follow the instructions on the form to complete the recall process.
The company said there have not been any patient complications reported due to issues with the device.
The company initiated a full recall Dec. 21, 2018.
Who to Contact for Information or Report Adverse Events
Customers with questions can contact Edward Lifesciences Technical Support Department at (800) 822-9837 option 1.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Healthcare professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.