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FDA Safety Alerts for Wednesday, February 6, 2019

February 6, 2019

The Food and Drug Administration (FDA) has issued the following safety alerts:


Recall: Edwards Lifesciences Swan-Ganz Thermodilution Catheters

Edwards Lifesciences is recalling the 131F7, 131F7J, 131F7P, 131VF7P, and 151F7 Swan-Ganz Thermodilution Catheters manufactured between December 26, 2017 and April 19, 2018 due to incorrect assembly and reversal of the catheter lumens. 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. More Information.


Recall: Sterile Saline and Sterile Water Products

Smiths Medical is recalling sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents from damaged packaging containers. These products are used in patients undergoing respiratory therapy, tracheal wash, or wound cleaning. The FDA issued this as a Class I recall, as use of these products in patients may result in serious and potentially life-threatening infections or death. More Information.


FDA Warns of Risks Associated with the Impella RP System

The FDA has issued a letter to healthcare providers regarding interim post-approval study data suggesting higher mortality rates in patients treated with the Impella RP System (Abiomed) than rates reported in the premarket clinical trials. The Impella RP System is a minimally invasive, miniaturized percutaneous circulatory support system to restore normal right heart hemodynamics, reduce RV work, and allow the right heart time to potentially recover adequate contractile function or to be bridged to the next therapy. The FDA recommends that healthcare providers report any adverse events or suspected adverse events experienced with the Impella RP System. More Information.