RemunityPRO DKUT-10006-001Recalls & reported problems
United Therapeutics Corporation · RemunityPRO Cassette Pack contains 10 RemunityPRO Cassettes · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850017421219), received between Apr 24, 2026 and Apr 24, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
- Fluid/Blood Leak1
- Infusion or Flow Problem1
- Wireless Communication Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Fluid/Blood Leak; Infusion or Flow Problem; Wireless Communication Problem
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 25-MAR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 26-MAR-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALARM AFTER FILLING THE CASSETTE ON REMUNITY PRO PUMP, SERIAL NUMBER (SN) (B)(6). UPON REMOVING THE CASSETTE, MEDICATION LEAKED INTO THE BOTTOM OF THE PUMP AND INTO THE BATTERY COMPARTMENT, AFTER WHICH, THE PUMP WOULD NOT POWER ON OR MAKE ANY SOUNDS, AND THE REMOTE DISPLAYED A "NO COMMUNICATION" MESSAGE. IT WAS ALSO REPORTED THAT THE PATIENT'S TWO PREVIOUS CASSETTES HAD LEAKED. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED ADDITIONAL CASSETTE LEAKS RESULTING IN DAMAGE TO THE PUMPS, WHILE USING REMUNITY PRO PUMPS, SNS (B)(6). THE PATIENT SUBSEQUENTLY EXPERIENCED AN INTERRUPTION IN THERAPY FOR APPROXIMATELY 12 HOURS. UPON TROUBLESHOOTING, IT WAS DISCOVERED THAT THE PATIENT WAS UTILIZING THE INCORRECT SIZE NEEDLE TO FILL THE CASSETTES. THE PATIENT WAS ADVISED TO REMOVE AND DISCARD ALL OF THE INCORRECTLY SIZED NEEDLES FROM THEIR SUPPLY. THE PATIENT REPORTED THAT THEY HAD ONE PUMP ON HAND THAT HAD NOT BEEN DAMAGED. THE PATIENT SUCCESSFULLY FI
Patient problems: Insufficient Information
MAUDE report 24987349 ↗
Other Pump, Infusion devices
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- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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