Blood Circuit Set UF 500-HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10853072007029), received between Jun 3, 2025 and Jun 3, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  (B)(6) HAD AN EXCESSIVE WEIGHT MISMATCH ALARM AFTER 40 HOURS OF THERAPY. NURSE RECEIVED "UF BAG FULL" ALARM. NURSE ONLY EMPTIED HALF THE BAG BECAUSE IT OVERFLOWED THE CONTAINER SHE WAS EMPTYING. NUWELLIS RECEIVED A CALL ABOUT THE WEIGHT MISMATCH, AND WE DETERMINED IT WAS BECAUSE SHE DID NOT FULLY EMPTY THE UF BAG BEFORE CONTINUING THERAPY. THE NURSE THEN EMPTIED THE REST OF THE UF ABOUT 15 MINUTES LATER TO HAVE AN EMPTY BAG. THE CALL ENDED. 17 MINUTES LATER WE RECEIVED ANOTHER CALL SAYING THAT THE PATIENT IS HYPOTENSIVE AND 100CC OF FLUID WAS PULLED IN THOSE 17 MINUTES WHEN UF IS SET AT 30CC/HR. BLOOD RETURNED, THERAPY DISCONTINUED, AND PT STABILIZED WITH FLUIDS. WE ASKED THE NURSE IF THE UF PUMP CARTRIDGE WAS IN CLIPPED IN PLACE AND SHE REPLIED YES. HOWEVER, WHEN NURSE WAS TAKING DOWN THE CIRCUIT, SHE NOTICED THAT THE UF CARTRIDGE WAS INDEED LOOSE. WE TOLD HER WE WILL STILL WANT THE CIRCUIT AND CONSOLE BACK AT CORPORATE TO RUN DIAGNOSTICS BUT THE UF CARTRIDGE BEING LOOSE CAN LEAD TO OVER-PULLING.

  Patient problems: Dehydration

  MAUDE report 22133892 ↗
• InjuryJun 3, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  THIS IS A FOLLOW-ON TO OUR MANUFACTURER REPORT # 3007137787-2024-00001, WITH THE SAME PATIENT ("PATIENT 1"). CUSTOMER REPORTS THAT WHILE ON AQUADEX SMARTFLOW THERAPY, WEIGHT MISMATCH ALARM OCCURED ON (B)(6) 2024; APPROXIMATELY 100 ML EXCESS WAS PULLED IN 45 MINUTES. CUSTOMER REPORTS "AGITATION RESTLESSNESS" AND THAT 2 BOLUSES OF FLUID WERE ORDERED (10 ML/KG EACH). ULTRAFILTRATION RATE WAS DROPPED TO ZERO IN RESPONSE TO WEIGHT MISMATCH ALARMS.

  Patient problems: Dehydration

  MAUDE report 22133883 ↗
• MalfunctionJun 3, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  THE FOLLOWING IS A DIRECT QUOTE FROM AN EMAIL FROM THE USER FROM 11/05/2024: "WE DID A SET CHANGE ON A PATIENT, AND WE STARTED HAVING UF WEIGHT MISMATCH ALARMS ON THE PATIENT. WE MONITORED THE PATIENT AND THE UF BAG, AND COMPARED WHAT THE MACHINE WAS SET TO PULL. IT DID APPEAR TO HAVE 100-200MLS TOO MUCH OFF IN A 3.5 HOUR PERIOD. THE PATIENT WAS FINE THE ENTIRE TIME AS WE WERE WATCHING FOR SIGNS / SYMPTOMS OF HYPOVOLEMIA, ETC. AND HAD A STRICT CRITLINE SET (WHICH THE PATIENT'S HCT WAS INCREASING OVER THIS TIME AND IT DID HIT THE LIMIT)." SUBSEQUENT COMMUNICATION WITH THE USER ON 11/14/2024 PROVIDED INFORMATION THAT THEY PROVIDED ADDITIONAL FLUIDS TO THE PATIENT IN ORDER TO ADDRESS THE EFFECTS OF UNINTENTIONAL REMOVAL OF EXCESS FLUID. ANALYSIS OF THE DATA LOGS FROM THE ASSOCIATED MACHINE INDICATE THAT TWELVE "UF WEIGHT MISMATCH" ALARMS OCCURED DURING THE RELEVANT FIVE HOUR PERIOD. THE ASSOCIATED DISPOSABLE BLOOD CIRCUIT (TUBING/FILTER SET) WAS RETURNED TO NUWELLIS FOR ANALYSIS. THE WEIGHT MISMATCH ISSUE WAS ABLE TO BE REPRODUCED WITH THIS TUBING SET USING A DIFFERENT CONSOLE/MACHINE, INDICATING A DEFECT WITH THIS DISPOABLE.

  Patient problems: Dehydration

  MAUDE report 22133245 ↗