FDA Drug recall · Reported September 19, 2018
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
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
United Therapeutics Corp. recalled Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation So… - a low-severity action.
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation So… was recalled by United Therapeutics Corp. in September 19, 2018. Reason: Defective Delivery System: Water ingress through the lower water cup sensor of the device.. Check the official notice for the remedy. Verify recall #D-1188-2018 with the FDA Drug before acting.
The recall
United Therapeutics Corp. issued this low-severity FDA Drug recall-Defective Delivery System: Water ingress through the lower water cup sensor of the device..
- Low
- severity level
- 3K units
- affected scope
- Class III
- classification
- September 19, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1188-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
Reason for recall
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1188-2018 |
| Date reported | September 19, 2018 |
| Date initiated | August 14, 2018 |
| Recalling firm | United Therapeutics Corp. |
| Firm location | Durham, NC |
| Affected scope | 2801 devices |
| Distribution | IL, PA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1188-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026