Remunity DKPI-11036-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850017421073), received between Jan 8, 2025 and Aug 27, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• MalfunctionApr 7, 2026Break

  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 WHILE THE PATIENT WAS PREPARING A NEW CASSETTE, IT "FELL APART." THE PATIENT MADE A SECOND ATTEMPT WITH THEIR LAST CASSETTE BUT REPORTED THAT THE SAME ISSUE OCCURRED. INFORMATION REGARDING HOW THE CASSETTES "FELL APART" WAS NOT CONFIRMED BY THE SPECIALTY PHARMACY. IT WAS FURTHER REPORTED THAT THE PATIENT HAD NO ADDITIONAL SUPPLIES ON HAND AND EXPERIENCED AN INTERRUPTION IN THERAPY. THE PATIENT ULTIMATELY PRESENTED TO THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 24809297 ↗
• MalfunctionFeb 27, 2026Break

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 29-JAN-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 30-JAN-2026. IT WAS REPORTED THAT THE PATIENT'S CASSETTE BROKE WHEN THEIR REMUNITY PUMP FELL. THE PATIENT DID NOT HAVE ANY MORE CASSETTES AVAILABLE AND EXPERIENCED AN INTERRUPTION IN THERAPY. IT WAS LATER REPORTED THAT THE PATIENT WAS HOSPITALIZED AND RESTARTED ON REMODULIN FROM THE HOSPITAL'S SUPPLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470735 ↗
• MalfunctionDec 10, 2025Fluid/Blood Leak; Difficult or Delayed Separation; Fluid/Blood Leak; Difficult or Delayed Separation

  AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 10-NOV-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 11-NOV-2025. THE PATIENT REPORTED BEING OUT OF REMODULIN SINCE 1:00 AM ON (B)(6) 2025. IT WAS COMMUNICATED THAT THE PATIENT'S MEDICATION VIAL WAS LEAKING, AND THAT THEIR LAST REMUNITY CASSETTE HAD LEAKED WHILE FILLING. THE PATIENT ALSO REPORTED THAT THEIR SON HAD TO DISCONNECT THEIR TUBING, BUT THEY HAD NO ADDITIONAL SUPPLIES ON HAND. ACCREDO HEALTH GROUP REPORTED THAT NO REMUNITY PRODUCT IS AVAILABLE FOR RETURN. REPORTABLE INFORMATION RELATED TO THIS EVENT WAS LATER RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 10-NOV-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 14-NOV-2025. THIS INFORMATION INDICATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025. ATTEMPTS MADE TO OBTAIN ADDITIONAL INFORMATION FROM ACCREDO HEALTH GROUP WERE UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 23771648 ↗
• MalfunctionJan 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AN INITIAL REPORT OF HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 16-DEC-2024 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 17-DEC-2024. THE PATIENT REPORTED THAT SHE WAS UNABLE TO FILL HER CASSETTES AND TROUBLESHOOTING WAS UNSUCCESSFUL. THE PATIENT WAS OFF REMODULIN FOR TWO HOURS AND WAS FEELING ANXIOUS BUT HAD NO OTHER SIDE EFFECTS. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THERE WERE NO REPORTED PUMP ISSUES. A REPLACEMENT VIAL OF REMODULIN WAS SENT. THE PATIENT WAS ABLE TO RESUME REMUNITY THERAPY AND WAS SCHEDULED TO BE DISCHARGED. NO COMPONENTS OR FURTHER INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Anxiety

  MAUDE report 21103391 ↗