Severity
Low
LowClass IIITerminated
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.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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 FDA Drug action (record #D-1188-2018) was formally reported on September 19, 2018, with the manufacturer initiating the action on August 14, 2018. It is classified under Low severity (Class III), with a current status of Terminated. United Therapeutics Corp. is listed as the recalling firm, operating out of Durham, NC. Federal records list the affected scope as 2801 devices.
The documented reason for this recall is: Defective Delivery System: Water ingress through the lower water cup sensor of the device. Distribution data in the federal record shows the product reached: IL, PA. Distribution scope 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
2801 devices
Related Recalls
6
0 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by United Therapeutics Corp.. Units affected: 2801 devices.
Why was this product recalled? ▼
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 19, 2018. Severity: Low. Recall number: D-1188-2018.
Where was the recalled product distributed? ▼
Distribution: IL, PA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1188-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported September 19, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.