RemunityPRO DKUT-11029-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00850017421233), received between Dec 18, 2025 and Apr 15, 2026 — classified as 1 death, 13 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026False Alarm; Wireless Communication Problem; Priming Problem

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON (B)(6) 2026 FROM (B)(6) AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON (B)(6) 2026. IT WAS REPORTED THAT THE PATIENT RECEIVED A "CASSETTE VOLUME LOW" ALERT EARLIER THAN EXPECTED WHILE USING ONE OF THEIR REMUNITYPRO PUMPS. THE PATIENT ATTEMPTED TO PRIME THEIR TUBING BUT WAS UNABLE TO SEE ANY MEDICATION AND FURTHER TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL. IT WAS ALSO REPORTED THAT THE PATIENT HAD MISPLACED ONE OF THEIR REMUNITYPRO REMOTES AND SUBSEQUENTLY EXPERIENCED AN INTERRUPTION IN THERAPY AS THEY WERE UNABLE TO RESUME THEIR INFUSION. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED PAIRING ISSUES BETWEEN THEIR REMUNITYPRO PUMPS (SERIAL NUMBERS (B)(6) AND (B)(6)) AND REMOTES AND PRESENTED TO THE EMERGENCY ROOM AFTER BEING WITHOUT REMODULIN FOR APPROXIMATELY SIX HOURS. THE PATIENT DENIED SYMPTOMS OR SIDE EFFECTS DURING THIS TIME. TROUBLESHOOTING EFFORTS BY THE PHYSICIAN AND EMERGENCY ROOM STAFF WERE ULTIMATELY SUCCESSFUL, FOLLOWING WHICH, THE PATIENT WAS ABLE TO RESUME THERAPY ON THEIR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889134 ↗
• MalfunctionApr 11, 2026Insufficient Device Problem Information

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY (B)(6) ON 11-MAR-2026 FROM (B)(6) SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 12-MAR-2026. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AFTER EXPERIENCING ISSUES WITH THEIR REMUNITYPRO SYSTEM. NO FURTHER INFORMATION REGARDING THE SPECIFIC TYPE OF DEVICE ISSUE WAS PROVIDED. WHILE HOSPITALIZED, THE PATIENT ELECTED TO TRANSITION FROM REMODULIN VIA THE REMUNITYPRO DEVICE, TO A NEW PULMONARY ARTERIAL HYPERTENSION MEDICATION. INFORMATION WAS RECEIVED FROM (B)(6) SPECIALTY PHARMACY ON 16-APR-2026 CONFIRMING THAT THE PATIENT HAD A BACKUP SYSTEM PRIOR TO THEIR HOSPITAL ADMISSION BUT IT IS UNKNOWN IF THE PATIENT ATTEMPTED TO SWITCH TO THAT SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 24847350 ↗
• MalfunctionApr 7, 2026Crack; Wireless Communication Problem

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 09-MAR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 10-MAR-2026. IT WAS REPORTED THAT DURING A ROUTINE CASSETTE CHANGE, THE PATIENT AND THEIR CAREGIVER ATTEMPTED TO SWITCH TO THE PATIENT'S BACKUP REMUNITYPRO SYSTEM BUT EXPERIENCED PAIRING ISSUES. THE PATIENT THEN ATTEMPTED TO USE THEIR OTHER REMUNITYPRO REMOTE AND PUMP BUT EXPERIENCED THE SAME ISSUES. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL. THE PATIENT'S CAREGIVER CONFIRMED THAT THE PATIENT HAD A THIRD PUMP (SERIAL NUMBER: (B)(6) THAT WAS WORKING, NOTING THAT THE THIRD REMOTE WAS CRACKED, BUT WAS STILL OPERATIONAL. REPLACEMENT SYSTEMS WERE ISSUED TO THE PATIENT BY THE SPECIALTY PHARMACY.

  Patient problems: Insufficient Information

  MAUDE report 24809299 ↗
• MalfunctionApr 7, 2026Insufficient Device Problem Information

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 09-MAR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 10-MAR-2026. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A STROKE. WHILE ADMITTED, THE PATIENT EXPERIENCED ISSUES WITH BOTH OF THEIR REMUNITYPRO PUMPS AND WAS TRANSITIONED TO INTRAVENOUS REMODULIN. NO INFORMATION REGARDING THE SPECIFIC TYPE OF DEVICE ISSUE WAS PROVIDED. REPLACEMENT SYSTEMS WERE ISSUED TO THE PATIENT BY THE SPECIALTY PHARMACY. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED NAUSEA AND LEG PAIN.

  Patient problems: Limb Pain; Nausea

  MAUDE report 24809298 ↗
• DeathApr 2, 2026Pumping Stopped; Wireless Communication Problem

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 06-MAR-2026 FROM (B)(6), INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 07-MAR-2026. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO COMMUNICATION ISSUES BETWEEN THEIR REMUNITY PRO PUMP AND REMOTE AND THEIR PUMP BEING IDLE. IT WAS LATER REPORTED THAT WHILE IN THE HOSPITAL, THE PATIENT EXPIRED ON (B)(6) 2026. NO INFORMATION REGARDING THE SPECIFIC CAUSE OF DEATH WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24769697 ↗
• MalfunctionMar 17, 2026Insufficient Device Problem Information

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 16-FEB-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 17-FEB-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITYPRO PUMP HAD STOPPED FUNCTIONING AS EXPECTED AND THE PATIENT RAN OUT OF MEDICATION. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL TO RESTART THEIR INFUSION WHILE AWAITING REPLACEMENT SUPPLIES FROM THE SPECIALTY PHARMACY. IT WAS FURTHER REPORTED THAT THE REMUNITYPRO PUMP WAS NOT REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 24621086 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak; Communication or Transmission Problem; Infusion or Flow Problem

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 19-JAN-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 20-JAN-2026. IT WAS REPORTED THAT FOLLOWING A CASSETTE CHANGE ON (B)(6) 2026, THE PATIENT'S REMUNITYPRO PUMP, SERIAL NUMBER (SN) (B)(6), WOULD NOT START AND THE REMOTE WOULD NOT ADVANCE PAST REPLACE THE BATTERY. THE PATIENT REMOVED THE CASSETTE IN AN ATTEMPT TO RESTART THE PROCESS AND OBSERVED LEAKING FROM THE CASSETTE. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED COMMUNICATION ERROR ALARMS. THE PATIENT RESUMED THEIR INFUSION ON THEIR BACKUP REMUNITYPRO SYSTEM AND A REPLACEMENT SYSTEM WAS ISSUED. INFORMATION RECEIVED ON 20-JAN-2026 FROM ACCREDO HEALTH GROUP, INC. INDICATED THAT ON 19-JAN-2026, A CASSETTE DEPLETED EARLIER THAN EXPECTED WHILE THE PATIENT WAS USING REMUNITYPRO PUMP, SN (B)(6), AND A PUMP ERROR ALARM OCCURRED. UPON REMOVAL OF THE CASSETTE, REMODULIN WAS REPORTEDLY OBSERVED INSIDE THE PUMP. A REPLACEMENT SYSTEM WAS ISSUED. INFORMATION RECEIVED ON 26-JAN-2026 FROM ACCREDO HEALTH GROUP, INC. STATED THAT ON (B)(6) 2026, THE PATIENT SWITCHED TO REMUNITYPRO PUMP, SN (B)(6), WHILE PERFORMING

  Patient problems: Insufficient Information

  MAUDE report 24463012 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak; Obstruction of Flow

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 21-JAN-2026 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 22-JAN-2026. IT WAS REPORTED THAT ON 14-JAN-2026, THE PATIENT DID NOT HAVE THEIR INFUSION SET TUBING FULLY SECURED AND MEDICATION LEAKED OUT ONTO THEIR SHIRT DURING THE NIGHT. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED AN OCCLUSION ALARM. THE PATIENT'S CAREGIVER RECONNECTED THE INFUSION USING A NEW CASSETTE. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS INCLUDING CHANGES IN BREATHING, DECREASED BLOOD OXYGEN SATURATION, AND DECREASED BLOOD PRESSURE, AS WELL AS LEG PAIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Limb Pain; Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 24394024 ↗
• MalfunctionFeb 19, 2026Device Difficult to Setup or Prepare

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 20-JAN-2026 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 22-JAN-2026. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED TO TRANSITION ONTO THE REMUNITYPRO SYSTEM. ON (B)(6) 2026, THE REMUNITYPRO SYSTEMS INTENDED FOR THE PATIENT REPORTEDLY FUNCTIONED WELL; HOWEVER, ON (B)(6) 2026, BOTH SYSTEMS REPORTEDLY ALARMED AND WOULD NOT COMPLETE THE SELF-TEST. IT WAS FURTHER REPORTED THAT ON (B)(6) 2026, THE PATIENT'S DAUGHTERS VISITED AND UNPLUGGED AND USED THE REMOTES, PUMPS, AND BATTERIES. TWO REPLACEMENT SYSTEMS WERE REQUESTED. IT WAS FURTHER REPORTED THAT THE PATIENT CONTINUED TO RECEIVE REMODULIN VIA THEIR CADD MS3 DEVICE WHILE INPATIENT AND HAD NOT YET STARTED THERAPY ON THE REMUNITYPRO SYSTEM AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394022 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak; Communication or Transmission Problem; Electrical Shorting

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 05-JAN-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 07-JAN-2026. IT WAS REPORTED THAT WHILE SETTING UP THE PATIENT'S DEVICE, REMUNITYPRO PUMP (SERIAL NUMBER (B)(6)) "SHORT CIRCUITED" AND MADE A "CRACKING" NOISE, AFTER WHICH THE PUMP WOULD NOT COMMUNICATE WITH ITS CORRESPONDING REMOTE. IT WAS FURTHER REPORTED THAT THE PATIENT'S SECOND REMUNITYPRO PUMP ALSO WOULD NOT CONNECT WITH ITS REMOTE. INFORMATION RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 06-JAN-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON (B)(6) 2026 REPORTED THAT THE PATIENT AND THEIR CAREGIVER HAD NOT NOTICED THAT THE CASSETTE IN USE WAS LEAKING REMODULIN. UPON EXPERIENCING THE CONNECTION ISSUES BETWEEN REMUNITYPRO PUMPS (SERIAL NUMBERS (B)(6) AND (B)(6)) AND THEIR CORRESPONDING REMOTES, REMODULIN INGRESS WAS REPORTEDLY OBSERVED IN THE PUMPS. THE PATIENT WAS ADVISED TO PRESENT TO THE EMERGENCY ROOM TO AWAIT REPLACEMENT REMUNITYPRO SYSTEMS. ADDITIONAL INFORMATION RECEIVED FROM ACCREDO HEALTH GROUP, INC., ON 27-JAN-2026 CONFIRMED THAT REPLACEMENT SYSTEMS WERE SENT TO THE HOSPITAL; HOWEVER, IT WAS UNKNO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257553 ↗
• MalfunctionFeb 3, 2026Insufficient Device Problem Information

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 05-JAN-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 06-JAN-2026. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO THEIR REMUNITYPRO PUMP AND INFUSION SITE FALLING TO THE FLOOR. NO FURTHER DETAILS REGARDING DEVICE CONDITION OR PERFORMANCE WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24251642 ↗
• MalfunctionJan 28, 2026Insufficient Device Problem Information

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 30-DEC-2025 FROM ACCREDO HEALTH GROUP, INC. AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 31-DEC-2025. IT WAS REPORTED THAT THE PATIENT'S TRANSITION TO THE REMUNITYPRO SYSTEM IN (B)(6) 2025 RESULTED IN THE PATIENT BEING HOSPITALIZED FOR THREE DAYS. AT THE TIME, THE PATIENT WAS UNABLE TO GET THE REMUNITYPRO PUMP TO WORK; HOWEVER, NO FURTHER DETAILS REGARDING THE SPECIFIC DEVICE ISSUE WERE PROVIDED. INFORMATION PROVIDED BY ACCREDO HEALTH GROUP, INC. INDICATED THAT THE DEVICE ISSUE HAD BEEN PREVIOUSLY RESOLVED AND THAT NO FURTHER INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 24203295 ↗
• MalfunctionJan 27, 2026Insufficient Device Problem Information

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 29-DEC-2025 FROM ACCREDO HEALTH GROUP, INC. AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 30-DEC-2025. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 DUE TO A RAPID HEART RATE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD TO EXCHANGE TWO CASSETTES PREMATURELY; HOWEVER, NO DETAILS REGARDING THE REASON FOR THE EXCHANGES WERE PROVIDED. THE PATIENT REPORTEDLY SWITCHED TO THEIR BACKUP REMUNITYPRO SYSTEM. INFORMATION PROVIDED BY ACCREDO HEALTH GROUP, INC. STATED THAT THE PATIENT'S THERAPY WAS INTERRUPTED FOR AN UNKNOWN DURATION AND IT WAS UNCLEAR WHETHER THE PATIENT'S INCREASED HEART RATE WAS RELATED TO THE PREMATURE CASSETTE EXCHANGES.

  Patient problems: Tachycardia

  MAUDE report 24191304 ↗
• MalfunctionDec 18, 2025Communication or Transmission Problem; Infusion or Flow Problem; Communication or Transmission Problem; Infusion or Flow Problem

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 29-OCT-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 30-OCT-2025. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT RECEIVED A PUMP FAILURE ALARM WHILE USING REMUNITYPRO PUMP, 25050132M, AND THEIR INFUSION WAS SUBSEQUENTLY STOPPED. THE PATIENT SWITCHED TO THEIR BACKUP REMUNITYPRO PUMP, 25050131M, BUT RECEIVED AN ADDITIONAL PUMP FAILURE ALARM ON (B)(6) 2025. REVIEW OF THE SYSTEM'S ALARM HISTORY BY THE PATIENT ALSO REVEALED THAT A NO COMMUNICATION ALARM HAD OCCURRED APPROXIMATELY ONE HOUR INTO THEIR INFUSION. REPORTABLE INFORMATION RELATED TO THIS EVENT WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 21-NOV-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 24-NOV-2025. THIS INFORMATION INDICATED THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 AND WAS ADMITTED TO THE HOSPITAL. REPLACEMENT PUMPS WERE SENT TO THE HOSPITAL AND A NURSE PERFORMED AN ONSITE VISIT FOR PATIENT RE-EDUCATION.

  Patient problems: Insufficient Information

  MAUDE report 23845890 ↗