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.
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.