United Therapeutics Corp. is recalling approximately 2,801 Tyvaso Inhalation System Patient Starter Kits and TD-300/A Replacement Device Kits. Tyvaso (treprostinil) is used to treat pulmonary arterial hypertension. The recall was initiated because water can leak through the device's lower water cup sensor (water ingress), which may cause the delivery system to malfunction. Consumers using these devices should contact their healthcare provider or pharmacist for guidance and to arrange for a replacement through the manufacturer.
Water leaking into the internal sensor of the inhalation device can cause the system to fail or provide inaccurate delivery of the medication treprostinil. This could lead to a disruption in the patient's prescribed treatment for pulmonary hypertension.
Contact healthcare provider and return product.
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Sources: FDA iRES · Raw API Response
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