RemunityRecalls & reported problems across all models
United Therapeutics Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 184
- Deaths reported
- 1
- Injuries reported
- 14
- Recalls
- 0
We found 2 models of Remunity by United Therapeutics Corporation in the FDA's device registry (GUDID). Together they are named in 184 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2021 and Sep 30, 2026 — classified as 1 death, 14 injuries, 169 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (91 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 Remunity problems
Device problems
- Insufficient Device Problem Information91
- Infusion or Flow Problem24
- Communication or Transmission Problem14
- Device Contamination with Chemical or Other Material9
- Wireless Communication Problem9
- False Alarm8
- Fluid/Blood Leak8
- Excess Flow or Over-Infusion7
Patient problems
- No Clinical Signs, Symptoms or Conditions82
- Insufficient Information50
- Dyspnea22
- Headache13
- Vomiting10
- Dizziness9
- Fatigue9
- Nausea6
Remunity models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Remunity DKPI-11042-001Infusion Pump, Drug Specific, Pharmacy-Filled1 death177 reports
- Remunity DKPI-11036-001Infusion Pump, Drug Specific, Pharmacy-Filled7 reports
Recent Remunity adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Infusion or Flow Problem
Patient problems: Dyspnea; Hypoxia; Low Oxygen Saturation
MAUDE report 50954806 ↗InjuryAug 28, 2026Unexpected Shutdown
An initial event notification was received by United Therapeutics Drug Safety on 31-JUL-2026 from (b)(6) , and forwarded to Millyard Advanced Medical Products, LLC, on 01-AUG-2026.The patient reported that their Remunity Pump, serial number (b)(6), would turn off during their infusion without generating any alarms. The patient stated their Remote showed adequate battery life at the time of the events, and they would only notice their infusion had stopped when they began to experience symptoms including shortness of breath, a stomach ache, dizziness, and presyncope when getting up to walk. It was confirmed that the patient had a functional backup system on hand to switch to, and a replacement Remunity system was sent by the (b)(6) Pharmacy.
Patient problems: Dizziness; Dyspnea; Presyncope
MAUDE report 50508831 ↗MalfunctionAug 27, 2026Detachment of Device or Device Component
An initial event notification was received by United Therapeutics Drug Safety on 28-JUL-2026 from CVS Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC, on 29-JUL-2026.The patient reported that on two separate occasions, the tubing detached from their Remunity Cassettes while they were in use and the Pumps were infusing. The patient stated this first occurred while they were sleeping and then again while they were at work. The patient confirmed they were able to promptly replace the Cassette each time and they did not have any delays in therapy or experience any symptoms.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485163 ↗InjuryAug 14, 2026Infusion or Flow Problem
Patient problems: Swelling/ Edema
MAUDE report 50256625 ↗MalfunctionAug 7, 2026Insufficient Device Problem Information; Wireless Communication Problem
An initial event notification was received by United Therapeutics Drug Safety on (b)(6) 2026 from CVS 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 Remunity systems, and the Remote displayed the message, "Verify Pump is delivering". Upon silencing the alarm, the patient stated that they were unable to get their Remote out of "searching mode". The patient further reported that their second Pump was not functioning as expected; however, no further information regarding the specific type of device issue was provided. The patient reported that they had recently received RemunityPRO systems and supplies for their planned transition onto the RemunityPRO system. The patient elected to transition to the RemunityPRO Pump early due to the reported issues with their Remunity Pumps.
Patient problems: Insufficient Information
MAUDE report 50180975 ↗MalfunctionJul 16, 2026Insufficient Flow or Under Infusion
Patient problems: Insufficient Information
MAUDE report 25850730 ↗MalfunctionJul 16, 2026Intermittent Infusion
Patient problems: Insufficient Information
MAUDE report 25850725 ↗MalfunctionJul 16, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25850724 ↗MalfunctionJul 9, 2026Crack; Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25764249 ↗MalfunctionJun 26, 2026Leak/Splash; Infusion or Flow Problem
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 05-JUN-2026 FROM ACCREDO SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 06-JUN-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED REPEATED CASSETTE-RELATED ALARMS WHILE USING BOTH OF THEIR REMUNITY PUMPS (SERIAL NUMBERS (B)(6)), AND THEY NOTED THEIR PUMP BATTERIES HAD BEEN WET FOR AN UNKNOWN PERIOD OF TIME. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPERIENCED AND INTERRUPTION IN THERAPY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2026 AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. REPLACEMENT REMUNITY SYSTEMS WERE SENT TO THE PATIENT BY THE SPECIALTY PHARMACY.
Patient problems: Insufficient Information
MAUDE report 25641918 ↗MalfunctionJun 26, 2026Detachment of Device or Device Component
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 03-JUN-2026 FROM ACCREDO SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 04-JUN-2026. IT WAS REPORTED THAT THE TUBING ON THE PATIENT'S REMUNITY CASSETTE HAD "BROKEN" AND THEY LOST REMODULIN OVERNIGHT. THE PATIENT FURTHER REPORTED THAT THIS ISSUE HAD OCCURRED 2-3 TIMES PRIOR, ALWAYS AT NIGHT WHILE THEY WERE SLEEPING. THE PATIENT CHANGED THE CASSETTES TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 25641914 ↗MalfunctionJun 25, 2026Insufficient Device Problem Information
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 26-MAY-2026 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 27-MAY-2026. IT WAS REPORTED THAT WHILE PERFORMING A CASSETTE CHANGE AT HOME, THE PATIENT EXPERIENCED ISSUES WITH TWO DIFFERENT REMUNITY USER-FILLED CASSETTES. IT WAS FURTHER REPORTED THAT THE PATIENT'S PUMP AND CASSETTES WERE "DAMAGED". NO FURTHER INFORMATION REGARDING THE REPORTED DEVICE ISSUES WAS PROVIDED. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY AS THEY HAD NO OTHER CASSETTES ON HAND. IT WAS ALSO NOTED THAT THE PATIENT WAS HYPOXIC AND EXPERIENCED LOW BLOOD PRESSURE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS PLACED ON INTRAVENOUS REMODULIN. REPLACEMENT SUPPLIES WERE SENT TO THE PATIENT BY THE SPECIALTY PHARMACY AND THEY ULTIMATELY RESUMED THERAPY ON THE REMUNITY SYSTEM AND WERE DISCHARGED FROM THE HOPSITAL.
Patient problems: Hypoxia; Low Blood Pressure/ Hypotension
MAUDE report 25627229 ↗MalfunctionJun 10, 2026False Alarm
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 11-MAY-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 12-MAY-2026. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT PERFORMED A ROUTINE CASSETTE CHANGE. THE FOLLOWING MORNING, THE PATIENT RECEIVED A PREMATURE CASSETTE DEPLETED ALARM AND SUBSEQUENTLY SWITCHED TO THEIR BACKUP REMUNITY PUMP USING A NEW CASSETTE. LATER THAT SAME DAY, THE PATIENT RECEIVED ANOTHER CASSETTE DEPLETED ALARM. THEY EXCHANGED THE PUMP BATTERY AND RECONNECTED THE SAME CASSETTE; HOWEVER, THE ALARM RETURNED APPROXIMATELY 45 MINUTES LATER. REPLACEMENT PUMPS WERE NOT ISSUED TO THE PATIENT AT THE TIME OF THIS EVENT. ON (B)(6) 2026 THE PATIENT REPORTED THAT THEY CONTINUED TO RECEIVE PREMATURE CASSETTE DEPLETED ALARMS WHILE USING BOTH REMUNITY PUMPS (SERIAL NUMBERS (B)(6) WITH NEW SELF-FILLED CASSETTES. DESPITE THIS, THE PATIENT CONFIRMED THEY WERE ABLE TO CONTINUE THEIR INFUSION ON ONE OF THEIR PUMPS AT THE TIME THE EVENT WAS REPORTED. REPORTABLE INFORMATION WAS RECEIVED ON 19-MAY-2026 BY ACCREDO SPECIALTY PHARMACY, INDICATING THAT THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY DUE T
Patient problems: Insufficient Information
MAUDE report 25462921 ↗MalfunctionJun 10, 2026Detachment of Device or Device Component
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 11-MAY-2026 FROM ACCREDO SPECIALTY PHARMACY, INC. AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 12-MAY-2026. THE PATIENT REPORTED THAT WHILE PERFORMING A SCHEDULED CASSETTE CHANGE, THEY NOTICED THAT THE TUBING HAD DETACHED FROM THE REMUNITY CASSETTE WHILE THE PUMP HAD BEEN IN THEIR POCKET. THE PATIENT OBSERVED THAT THE CASSETTE APPEARED TO BE FULL AND STATED THEY HAD POSSIBLY BEEN WITHOUT REMODULIN FOR TWO DAYS. THE PATIENT EXPERIENCED FATIGUE AT THE TIME OF THE EVENT.
Patient problems: Fatigue
MAUDE report 25462918 ↗MalfunctionJun 5, 2026Insufficient Device Problem Information
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 07-MAY-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 08-MAY-2026. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND REQUESTED REMUNITY PUMP REPLACEMENTS. NO INFORMATION WAS PROVIDED REGARDING A SPECIFIC REASON FOR THE HOSPITALIZATION OR TYPE OF DEVICE ISSUE.
Patient problems: Insufficient Information
MAUDE report 25416526 ↗
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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