FDA Issues Labeling Correction for Optease Retrievable Vena Cava Filter

The Food and Drug Administration (FDA) on Aug. 8 notified health care professionals of a labeling correction for the Optease Retrievable Vena Cava Filter, used to prevent recurrent pulmonary embolism in certain situations. The labeling correction was made “to provide clarification and additional information to minimize likelihood of implanting the filter backwards.” In April, ahead of the FDA’s notification, Cordis Corporation issued an "URGENT Medical Device Correction" to their customers. Read the complete alert.

Clinical Topics: Vascular Medicine

Keywords: Pulmonary Embolism, United States Food and Drug Administration, Vena Cava Filters, Vena Cava, Inferior

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