Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Recalled by United Therapeutics Corp. Due to Defective Delivery System: Water ingress through the lower...

Date: August 14, 2018
Company: United Therapeutics Corp.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact United Therapeutics Corp. directly.

Affected Products

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

Quantity: 2801 devices

Why Was This Recalled?

Defective Delivery System: Water ingress through the lower water cup sensor of the device.

Where Was This Sold?

This product was distributed to 2 states: IL, PA

Affected (2 states)Not affected

About United Therapeutics Corp.

United Therapeutics Corp. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report