PHOENIX 6023006700Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07332414042035), received between Mar 16, 2019 and Mar 19, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A PHOENIX MACHINE DURING HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639627 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A PHOENIX MACHINE DURING HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500207 ↗
• MalfunctionJan 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A PHOENIX MACHINE DURING HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023708 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A PHOENIX/INNOVA MACHINE DURING HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975366 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A PHOENIX MACHINE DURING HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22419293 ↗
• MalfunctionNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED IN THE LOWER TRAY OF A PHOENIX MACHINE DURING HEMODIALYSIS THERAPY. NO ALARMS WERE GENERATED BY THE MACHINE AT THE TIME OF THE REPORTED LEAKAGE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20740314 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM THE BLOOD LEAK DETECTOR HOUSING OF A PHOENIX MACHINE DURING HEMODIALYSIS THERAPY. NO ALARMS WERE GENERATED BY THE MACHINE AT THE TIME OF THE REPORTED LEAKAGE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467489 ↗
• InjuryMay 31, 2023Inadequate Ultra Filtration; Inadequate Ultra Filtration

  IT WAS REPORTED THAT DURING TREATMENT WITH A PHOENIX MACHINE, THE MACHINE ULTRAFILTERED MORE THAN EXPECTED. THE PATIENT¿S PRE-TREATMENT WEIGHT WAS 64,2 KG, AND THE WEIGHT AFTER TREATMENT WAS 62,8KG, INDICATING THAT TOTAL WEIGHT LOSS (TWL) WAS 1,4KG, WHILE SET TWL WAS 0,5KG. THE PATIENT PRESENTED WITH CRAMPS AND A BOLUS OF SALINE WAS ADMINISTERED (AMOUNT OF BOLUS NOT REPORTED). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 17031148 ↗
• MalfunctionFeb 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A PHOENIX MACHINE, AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE CONNECTOR OF THE ELECTRO VALVE EV2. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310975 ↗
• MalfunctionAug 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING TREATMENT WITH A PHOENIX MACHINE, A PATIENT EXPERIENCED A HIGH ULTRAFILTRATION. IT WAS REPORTED THAT THE PATIENT'S POST WEIGHT WAS ABOUT 2.9 KG LOWER THAN THE PRE WEIGHT. THE CUSTOMER STATED THAT THE NET ULTRAFILTRATION (UF) REMOVED WAS 1.09L DURING DIALYSIS. IT WAS REPORTED THAT THE HEMODIALYSIS (HD) MACHINE WAS SHOWING D1-D2 ERROR MESSAGES, RESET THE HD MACHINE WAS PERFORMED AND THE D1-D2 ERROR MESSAGES STOPPED SHOWING. IT WAS REPORTED THAT IN THE LAST 45 MINUTES, D1-D2 ERROR MESSAGES KEPT SHOWING AGAIN AND APPROXIMATELY 30 MINUTES REMAINING FOR TREATMENT, THE VENOUS PRESSURE WENT UP TO "300S". THE CUSTOMER DECIDED TO STOP HD IN ORDER TO PREVENT BLOODLINE CLOTTING AND BLOOD WAS RETURNED TO THE PATIENT. IT WAS REPORTED THAT THE PATIENT FELT DRY, HOWEVER, THEIR BLOOD PRESSURE WAS 129/73 MMHG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338169 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC ARREST WHILE UNDERGOING TREATMENT WITH A PHOENIX DIALYSIS MACHINE. THE CAUSE OF THE EVENT WAS NOT REPORTED. TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 8526849 ↗
• InjuryMar 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT BEING TREATED WITH A PHOENIX DIALYSIS MACHINE EXPERIENCED A CARDIAC EVENT WITHIN MINUTES OF STARTING THERAPY. RESUSCITATION ATTEMPT WAS SUCCESSFUL AND THE PATIENT WAS HOSPITALIZED. THE CAUSE OF THE EVENT WAS UNKNOWN. NO FURTHER MEDICAL INTERVENTION WAS REPORTED. HOSPITALIZATION WAS ONGOING AT THE TIME OF THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 8426545 ↗