FDA Slaps Class I Recall on Sapien 3 Ultra for TAVR

Patrice Wendling


August 22, 2019

The US Food and Drug Administration (FDA) today issued a class I recall of the Sapien 3 Ultra delivery system, used to deploy the Edwards Lifesciences transcatheter heart valve in patients with aortic stenosis.

As previously reported, the device maker warned physicians last month that it had received an unspecified number of reports that balloon bursts have resulted in "significant difficulty" in retrieving the valve into the catheter and withdrawing the system from the patient.

The FDA release now warns that use of the product "may cause serious adverse health consequences, including death," and that 17 injuries and one death were reported at the time of Edwards' July urgent field notice.

Health Canada also issued a type 1 medical device recall on July 16 for the Sapien 3 Ultra, indicating that the device "may be hazardous to health."

The Sapien 3 Ultrasystem received CE mark approval in Europe in November 2018 and FDA approval the following month.

Patients in the United States who have undergone transcatheter valve replacement since January 3 in which the Sapien 3 Ultra was used "may be affected," according to the FDA.

The recall includes 1585 devices manufactured between January 23, 2018, and July 26, 2019, and distributed from January 3, 2019, to the present.

Edwards field notice indicates that "excess inflation volume and fast inflation conditions" may influence the frequency of balloon bursts. The company provides physicians with recommendations as to how to avoid the problem. A warning is also being added to the system's instructions for use.

Healthcare professionals and consumers may report adverse events or quality problems related to the affected devices to the FDA's MedWatch program.

Follow Patrice Wendling on Twitter: @pwendl

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