Devices Used with Tyvaso Therapy Being Recalled

United Therapeutics announced a voluntary recall of the medical devices Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A due to incorrect software programming.

The recall of 188 units was initiated after the discovery that these devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.

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The Tyvaso Inhalation System is intended for use with Tyvaso (treprostinil; United Therapeutics), a prostacyclin analogue indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III symptoms to improve exercise ability in adults.

For a full list of the affected lots and serial numbers, visit FDA.gov.

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