RemunityPRORecalls & reported problems across all models
United Therapeutics Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 60
- Deaths reported
- 3
- Injuries reported
- 11
- Recalls
- 0
We found 3 models of RemunityPRO by United Therapeutics Corporation in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Dec 18, 2025 and Sep 25, 2026 — classified as 3 deaths, 11 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (20 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RemunityPRO problems
Device problems
- Insufficient Device Problem Information20
- Pumping Stopped19
- Wireless Communication Problem14
- Infusion or Flow Problem12
- Fluid/Blood Leak8
- Leak/Splash5
- Obstruction of Flow5
- Communication or Transmission Problem3
Patient problems
- Insufficient Information37
- No Clinical Signs, Symptoms or Conditions13
- Fatigue2
- Limb Pain2
- Low Oxygen Saturation2
- Pulmonary Hypertension2
- Anxiety1
- Chest Pain1
RemunityPRO models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RemunityPRO DKUT-21073-007Pump, Infusion2 deaths45 reports
- RemunityPRO DKUT-11029-007Pump, Infusion1 death14 reports
- RemunityPRO DKUT-10006-001Pump, Infusion1 report
Recent RemunityPRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Insufficient Device Problem Information; Wireless Communication Problem
Patient problems: Insufficient Information
MAUDE report 50892691 ↗InjurySep 24, 2026Pumping Stopped
The patient reported that they received Pump Failure alarms while using RemunityPRO Pumps, serial numbers (b)(6). The patient presented to the Emergency Room and was started on intravenous Remodulin while awaiting replacement RemunityPRO systems. It was later reported that the patient was able to successfully resume therapy on one of their replacement RemunityPRO Pumps.
Patient problems: Insufficient Information
MAUDE report 50876775 ↗InjurySep 24, 2026Leak/Splash; Pumping Stopped; Wireless Communication Problem
The patient reported that their RemunityPRO Pumps and Remotes were not functioning as expected, and they experienced syncing/pairing issues. The patient reported that one of their RemunityPRO Pumps emitted an unusual static noise and upon its removal, a Cassette leak was observed. The patient replaced the Cassette; however, when attempting to restart their infusion, the Pump and Remote "became unresponsive". After several failed attempts to restart the Pump, the patient performed a factory reset. Following the reset, the Pump was successfully paired to its corresponding Remote, but the patient received an alarm with a message to switch to their backup System. The patient further reported that their second Pump also showed signs of moisture. The patient stated they performed a factory reset for their second RemunityPRO system as well, following which, they received alarms and the devices "became unresponsive". The patient experienced an interruption in therapy and stated they were anxious and "close to a panic attack" due to the events. Replacement RemunityPRO systems were couriered to the patient from the Specialty Pharmacy.
Patient problems: Anxiety
MAUDE report 50876772 ↗MalfunctionSep 18, 2026Pumping Stopped; Insufficient Device Problem Information
Patient problems: Confusion/ Disorientation; Fatigue
MAUDE report 50829563 ↗MalfunctionSep 17, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50812171 ↗MalfunctionAug 28, 2026No Display/Image; Pumping Stopped
Patient problems: Insufficient Information
MAUDE report 50508834 ↗MalfunctionAug 27, 2026Pumping Stopped
An initial event notification was received by United Therapeutics Drug Safety on (b)(6)2026 from Accredo Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC, on (b)(6)2026.The patient reported that they received a Pump Failure alarm while using RemunityPRO Pump, serial number (b)(6). The patient further stated that they had misplaced their backup Pump. A replacement system was couriered to the patient by the Specialty Pharmacy.
Patient problems: Insufficient Information
MAUDE report 50485164 ↗InjuryAug 27, 2026Insufficient Device Problem Information
An initial event notification was received by United Therapeutics Drug Safety on 28-JUL-2026 from Accredo Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC, on 29-JUL-2026.The patient reported that their RemunityPRO Pump, serial number (b)(6), stopped functioning as expected. The patient subsequently presented to the Emergency Room and was ultimately admitted to the hospital. A replacement system was sent by the Specialty Pharmacy, and the patient was later discharged home.
Patient problems: Insufficient Information
MAUDE report 50485162 ↗InjuryAug 27, 2026Insufficient Device Problem Information
An initial event notification was received by United Therapeutics Drug Safety on (b)(6)2026 from Accredo Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC, on (b)(6)2026.The patient reported that they received an alarm while using one of their RemunityPRO Pumps on (b)(6)2026, and subsequently switched to their backup System. On the morning of (b)(6)2026, the patient received the same alarm from their backup System. The patient stated they began feeling "bad", so they presented to the Emergency Department and were ultimately admitted for pulmonary hypertension symptoms. The patient was placed on intravenous Remodulin and replacement RemunityPRO Systems were sent by the Specialty Pharmacy. The patient was later discharged.
Patient problems: Pulmonary Hypertension
MAUDE report 50465830 ↗InjuryAug 27, 2026Pumping Stopped
An initial event notification was received by United Therapeutics Drug Safety on 27-JUL-2026 from Accredo Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC, on 28-JUL-2026.The patient reported that they received a Pump Failure alarm while using one of their RemunityPRO Pumps. The patient was unable to switch to their backup System as they had misplaced their backup Pump. The patient was admitted to the hospital to receive intravenous Remodulin while awaiting replacement systems from the Specialty Pharmacy.
Patient problems: Insufficient Information
MAUDE report 50465828 ↗MalfunctionAug 27, 2026Pumping Stopped
An initial event notification was received by United Therapeutics Drug Safety on 27-JUL-2026 from Accredo Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC, on 28-JUL-2026.The patient reported that they received Pump Failure alarms while using both of their RemunityPRO Pumps, serial numbers (b)(6). The patient was unable to resolve the alarms and replacement RemunityPRO Systems were sent by the Specialty Pharmacy.
Patient problems: Insufficient Information
MAUDE report 50465827 ↗MalfunctionAug 14, 2026Break; Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246126 ↗InjuryAug 14, 2026Pumping Stopped; Infusion or Flow Problem
An initial event notification was received by United Therapeutics Drug Safety on (b)(6) 2026 from Accredo Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC, on (b)(6) 2026.It was reported that the patient received Pump Failure alarms while using both of their RemunityPRO Pumps, serial numbers (b)(6). The patient experienced an interruption in therapy but denied any adverse side effects. It was further reported that after performing a Cassette change for Pump (b)(6), the patient was able to restart their infusion; however, they were unable to titrate up to the correct delivery rate as they had forgotten their System passcode. The patient's caregiver later reported that the patient had been admitted to the hospital for evaluation and medical management as they had been off Remodulin for an extended period of time. Replacement systems were sent to the patient by the Specialty Pharmacy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246125 ↗MalfunctionAug 14, 2026Leak/Splash; Failure to Power Up; Pumping Stopped
Patient problems: Insufficient Information
MAUDE report 50246122 ↗InjuryAug 14, 2026False Alarm; Infusion or Flow Problem
Patient problems: Low Oxygen Saturation; Syncope/Fainting
MAUDE report 50246121 ↗
Other United Therapeutics Corporation products
All United Therapeutics Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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