Tyvaso Inhalation System (United Therapeutics) – Defective Device (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709
Brand
United Therapeutics Corp.
Lot Codes / Batch Numbers
Lot number a) 2101503, 2101507, 2101523, 2101532, 2101533, EXP 07/31/2019, 2101557, EXP 11/30/2019 b) Lot # 2101504, EXP 4/24/2021, 2101509, 2101522, EXP 5/8/2021, 2101531, EXP 5/15/2021, 2101534, EXP 6/10/2021, 2101543, EXP 6/14/2021, 2101558, EXP 7/26/2021
Products Sold
Lot number a) 2101503, 2101507, 2101523, 2101532, 2101533, EXP 07/31/2019; 2101557, EXP 11/30/2019 b) Lot # 2101504, EXP 4/24/2021; 2101509, 2101522, EXP 5/8/2021; 2101531, EXP 5/15/2021; 2101534, EXP 6/10/2021; 2101543, EXP 6/14/2021; 2101558, EXP 7/26/2021
United Therapeutics Corp. is recalling Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Tre due to Defective Delivery System: Water ingress through the lower water cup sensor of the device.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, PA
Page updated: Jan 7, 2026