United Therapeutics Recalls Tyvaso Inhalation Systems Due to Software Defect
United Therapeutics is voluntarily recalling Tyvaso Inhalation Systems with specific medical devices that may have incorrect software, potentially causing them to not operate as instructed.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a software defect that may cause the device to not operate as indicated, but no injuries or illnesses have been reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
United Therapeutics Corporation is voluntarily recalling a small number of Tyvaso Inhalation Systems. The recall involves systems equipped with Optineb ON-100/7 and TD-100/A medical devices. The affected products are Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only.
The reason for the recall is that these devices may have been programmed with a different software version than intended. If the device contains the incorrect software, it may not operate as indicated in the Instructions for Use. The source text does not report any illnesses, injuries, or deaths associated with this defect.
The recall affects 188 units distributed in Florida and Texas. Specific lot numbers and serial numbers for the affected TD-100 and Optineb devices are listed in the official recall documentation. Consumers and healthcare providers should check their devices against the provided serial numbers and contact United Therapeutics for further instructions.
The recalled product
- Product
- Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
- Manufacturer
- United Therapeutics Corp.
- Affected units
- 188
Distribution
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