FDA News

FDA designates recall of thermodilution catheters as class 1

The FDA has designated Edwards Lifesciences’ product recall of thermodilution catheters used in patients who require intensive monitoring or are undergoing complex surgery such as open heart surgery as a class 1 recall, the most serious kind. The recall affects 1,426 catheters manufactured and distributed between Dec. 26, 2017, and Aug. 20, 2018.

Incorrect assembly and reversal of the lumens in the catheter (Swan-Ganz thermodilution catheter, Edwards Lifesciences), used to measure BPs in the heart, veins and arteries, blood oxygen levels and blood flow, may result in inaccurate pulmonary artery and central venous pressure values and waveforms in addition to unintended treatment, according to a MedWatch report from the FDA. These inaccuracies may also lead to incorrect catheter placement and an increased risk for blood vessel perforation.

Edwards Lifesciences distributed a letter to customers on Dec. 12 informing them of the affected model/lot numbers, instructions to return any unused units and to contact the company for further information and support.

The FDA has designated Edwards Lifesciences’ product recall of thermodilution catheters used in patients who require intensive monitoring or are undergoing complex surgery such as open heart surgery as a class 1 recall, the most serious kind. The recall affects 1,426 catheters manufactured and distributed between Dec. 26, 2017, and Aug. 20, 2018.

Incorrect assembly and reversal of the lumens in the catheter (Swan-Ganz thermodilution catheter, Edwards Lifesciences), used to measure BPs in the heart, veins and arteries, blood oxygen levels and blood flow, may result in inaccurate pulmonary artery and central venous pressure values and waveforms in addition to unintended treatment, according to a MedWatch report from the FDA. These inaccuracies may also lead to incorrect catheter placement and an increased risk for blood vessel perforation.

Edwards Lifesciences distributed a letter to customers on Dec. 12 informing them of the affected model/lot numbers, instructions to return any unused units and to contact the company for further information and support.