RemunityPRO DKUT-21073-007Recalls & reported problems
United Therapeutics Corporation · RemunityPRO Pump · Class 2
Quick summary
This RemunityPRO infusion pump has 40 adverse event reports, including 2 deaths and 8 injuries; 30 are malfunctions. Reports mainly describe pumping stopping, interrupted flow, leaks and alarms. No recalls name this device. There were 0 reports in the prior period and 40 in the latest.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 2
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00850017421240), received between Apr 11, 2026 and Sep 25, 2026 — classified as 2 deaths, 11 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (18 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Pumping Stopped18
- Insufficient Device Problem Information14
- Wireless Communication Problem10
- Infusion or Flow Problem9
- Leak/Splash5
- Fluid/Blood Leak4
- Obstruction of Flow4
- Failure to Power Up2
Patient problems
- Insufficient Information28
- No Clinical Signs, Symptoms or Conditions10
- Fatigue2
- Pulmonary Hypertension2
- Anxiety1
- Chest Pain1
- Confusion/ Disorientation1
- Dizziness1
Recent adverse event reports
The 25 most recent of 45 reports, 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 ↗MalfunctionAug 13, 2026Infusion or Flow Problem
Patient problems: Insufficient Information
MAUDE report 50230643 ↗MalfunctionAug 13, 2026Leak/Splash
Patient problems: Insufficient Information
MAUDE report 50230641 ↗MalfunctionAug 7, 2026Leak/Splash; Failure to Pump; Pumping Stopped
An initial event notification was received by United Therapeutics Drug Safety on 10-JUL-2026 from Accredo Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC on 11-JUL-2026.The patient's caregiver reported that medication from a Cassette had leaked into the patient's RemunityPRO Pump, serial number: (b)(6), and the system displayed a Pump Failure alarm. It was further stated that a "humming" noise was observed when a battery was inserted into the Pump. The patient's caregiver also reported that the patient's second RemunityPRO Pump, serial number: (b)(6), would not complete the self-test. After several failed attempts to troubleshoot, the system generated a Pump Failure alarm. The patient experienced an interruption in therapy but denied any symptoms. Two replacement systems were couriered to the patient by the Specialty Pharmacy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50180976 ↗InjuryAug 7, 2026Wireless Communication Problem
An initial event notification was received by United Therapeutics Drug Safety on 10-JUL-2026 from CVS Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC on 11-JUL-2026.It was reported that the patient was unable to pair the RemunityPRO Pumps with their corresponding Remotes. Troubleshooting efforts were unsuccessful and the patient subsequently experienced an interruption in therapy. The patient reported that they would present to the hospital for supportive care and replacement RemunityPRO systems were sent by the Specialty Pharmacy.
Patient problems: Insufficient Information
MAUDE report 50180974 ↗MalfunctionAug 7, 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 Pump Failure alarms while using both of their RemunityPRO Pumps, serial numbers (b)(6) and (b)(6) ,which were unable to be resolved with troubleshooting. The patient was reportedly without medication for approximately 9-10 hours and experienced fatigue. Replacement systems were couriered to the patient by the Specialty Pharmacy.
Patient problems: Fatigue
MAUDE report 50180973 ↗InjuryAug 7, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50168687 ↗MalfunctionAug 7, 2026Leak/Splash; Infusion or Flow Problem; Wireless Communication Problem
Patient problems: Insufficient Information
MAUDE report 50168686 ↗MalfunctionAug 7, 2026Pumping Stopped; Obstruction of Flow; Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168685 ↗InjuryJul 29, 2026Infusion or Flow Problem
An initial event notification was received by United Therapeutics Drug Safety on 29-JUN-2026 from Accredo Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC on 30-JUN-2026.It was reported that the patient received persistent Pump Failure alarms while using RemunityPRO Pumps, serial numbers (b)(6). The patient was ultimately admitted to the hospital, but denied any symptoms. Replacement systems were couriered to the patient by the Specialty Pharmacy and the patient successfully resumed therapy on one of the new RemunityPRO Pumps.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074838 ↗MalfunctionJul 16, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25850727 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.