PRISMAFLEX SET 107640USRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00085412917696), received between Mar 28, 2024 and Aug 3, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K212216); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jan 6, 2026Open, Classified

   There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

   Z-1225-2026 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50118813 ↗
• MalfunctionMay 28, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX ST150 SET. THE PRE BLOOD PUMP LUER LOCK BROKE DURING A BAG CHANGE. 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 25316780 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT THE LUER CONNECTOR OF A PRISMAFLEX ST 150 SET WAS OBSERVED TO BE BROKEN DURING CONTINUOUS RENAL REPLACEMENT THERAPY. TREATMENT WAS DISCONTINUED WHEN "RISING FILTER PRESSURES" OCCURRED AND ON DISCONNECTION, THE ACCESS CONNECTOR WAS NOTED TO BE STUCK INSIDE THE PATIENT CATHETER. THE EXTRACORPOREAL BLOOD WAS NOT RETURNED. 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 25316158 ↗
• MalfunctionMay 8, 2026Obstruction of Flow

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH TWO (2) PRISMAFLEX ST150 SETS AND A PRISMAFLEX MACHINE, TREATMENT WAS DISCONTINUED TWICE WHEN A "FLOW RATE ALARM PERSISTED". THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT IN EITHER INSTANCE BECAUSE IT WAS "TOO COAGULATED". THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126029 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE REPLACEMENT LINE NEAR THE DEAERATION CHAMBER OF A PRISMAFLEX ST150 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083626 ↗
• MalfunctionApr 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PRISMAFLEX ST150 SET "FILTER STARTED LEAKING AT THE BOTTOM WHERE THE FILTER MEETS THE TUBING AFTER THE PRIME TEST WAS PERFORMED.". 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 24877896 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH TWO (2) PRISMAFLEX ST 150 SETS, THE "EFFLUENT WAS NOTED TO BE DISCOLORED IMMEDIATELY AFTER THERAPY BEGAN." THE SETS WERE REPLACED TWICE TO CONTINUE TREATMENT AND THE EXTRACORPOREAL BLOOD WAS NOT RETURNED. THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744195 ↗
• MalfunctionMar 24, 2026Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PRISMAFLEX ST150 SET US HAS MULTIPLE POINTS THAT EASILY CAME DISCONNECTED UNLESS PURPOSEFULLY SECURED WELL. IT WAS FURTHER REPORTED THAT THE "RETURN LINE AT POINT OF ENTRY INTO HEMOFILTER CAME DISCONNECTED DURING PRIMING WITH SALINE/HEPARIN" AND "SPRAYED ON THE NURSE". THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO INJURY REPORTED AND NO MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680891 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS RECEIVING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT USING PRISMAFLEX ST150 SET. IT WAS REPORTED THAT, DURING THERAPY, HEMATURIA AND BLOOD IN THE EFFLUENT WERE OBSERVED. THE PATIENT UNDERWENT UNSPECIFIED BLOOD INVESTIGATIONS AND WAS REPORTED TO EXPERIENCE HEMOLYSIS. TREATMENT WAS STOPPED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hematuria; Hemolysis

  MAUDE report 24606033 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING OF A PRISMAFLEX ST 150 SET, AN EXTERNAL LEAK WAS OBSERVED. IT WAS FURTHER REPORTED THAT THERE WAS NO CLAMP ON THE HEPARIN LINE OF THE FILTER.THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484251 ↗
• MalfunctionFeb 23, 2026Air/Gas in Device

  IT WAS REPORTED THAT AN "AIR IN LINE" EVENT WAS OBSERVED DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX ST150 SET, DESCRIBED AS "THERE WERE AIR BUBBLES AT THE START OF PRE-BLOOD-PUMP (PBP) PERISTALTIC PUMP ROLLER AND FLUID WAS GOING TO THE ROLLER AND AIR BUBBLES WHEN IT EXITS THE ROLLERS". THE SET ACCESS LINE TO THE PATIENT HAD "BLOOD FROM THE PATIENT TO THE PBP LINE INTERSECTION BUT WAS ALL AIR AFTER THAT TO THE SAFETY CLAMP". THERE WAS NO MACHINE ALARM NOTED. THIS OCCURRED TWO (2) TIMES WITH THE SAME PATIENT USING TWO (2) DIFFERENT SETS. BOTH SETS WERE REPLACED TO CONTINUE TREATMENT WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT EITHER TIME. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422381 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LUER LOCK CONNECTION BETWEEN A PRISMAFLEX ST150 SET AND A THERMAX BLOOD WARMER DISPOSABLE WAS LOOSE AND ALLOWED BLOOD LEAKAGE DURING CONTINUOUS RENAL REPLACEMENT THERAPY, DESCRIBED AS "BLOOD WAS SPRAYED OVER THREE NURSES". THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420711 ↗
• MalfunctionJan 5, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL LEAK FLUID WAS OBSERVED FROM THE DEAERATION CHAMBER OF A PRISMAFLEX ST150 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958187 ↗
• MalfunctionDec 11, 2025Crack; Incomplete or Inadequate Connection; Crack; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE "GREEN CONNECTOR ON THE SYRINGE LINE" OF A PRISMAFLEX ST150 SET WAS OBSERVED TO BE CRACKED AND COULD NOT CONNECT CORRECTLY DURING CONTINUOUS RENAL REPLACEMENT 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 23777846 ↗
• MalfunctionNov 19, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE BROKEN DEAERATION CHAMBER OF A PRISMAFLEX ST150 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595006 ↗
• MalfunctionOct 28, 2025Fluid/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 FROM THE DISCONNECTED EFFLUENT LINE OF A PRISMAFLEX ST150 SET DURING CONTINUOUS RENAL REPLACEMENT 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 23406321 ↗
• MalfunctionSep 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ¿WHITE PRECIPITATE¿ WAS OBSERVED IN THE FILTER OF A PRISMAFLEX ST150 SET DURING USE FOR 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 23057286 ↗
• MalfunctionSep 10, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A "LARGE AIR POCKET" WAS OBSERVED IN THE FILTERS OF TWO (2) PRISMAFLEX ST150 SETS FROM DIFFERENT LOTS DURING CONTINUOUS RENAL REPLACEMENT THERAPY ON TWO (2) DIFFERENT PRISMAX MACHINES. A TOTAL OF TWO (2) INCIDENTS OCCURRED ON ONE (1) PATIENT. THE TREATMENT WAS ENDED BOTH TIMES AND THE BLOOD WAS NOT RETURNED TO THE PATIENT. THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017087 ↗
• MalfunctionSep 10, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A "LARGE AIR POCKET" WAS OBSERVED IN THE FILTERS OF TWO (2) PRISMAFLEX ST150 SETS FROM DIFFERENT LOTS DURING CONTINUOUS RENAL REPLACEMENT THERAPY ON TWO (2) DIFFERENT PRISMAX MACHINES. A TOTAL OF TWO (2) INCIDENTS OCCURRED ON ONE (1) PATIENT. THE TREATMENT WAS ENDED BOTH TIMES AND THE BLOOD WAS NOT RETURNED TO THE PATIENT. THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016954 ↗
• MalfunctionJun 19, 2025Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT CLOTTING WAS OBSERVED IN TWO (2) PRISMAFLEX ST150 SETS DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAX MACHINE. THE MACHINE WAS REPLACED TO CONTINUE TREATMENT. 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 22293902 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS RECEIVING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT USING PRISMAFLEX ST 150 SET. IT WAS REPORTED THAT THE CONTROL UNIT GENERATED AN ALARM AND IT FOUND THAT A ¿PORTION OF THE CIRCUIT FROM THE ACCESS PRESSURE SENSOR POD TO THE BLOOD PUMP WOULD BE FILLED WITH AIR¿. IT WAS REPORTED THAT 15-16 "CIRCUITS" WERE USED BETWEEN THIS PATIENT AND ANOTHER PATIENT. THE PATIENT¿S TREATMENT WAS TERMINATED WITHOUT THE EXTRACORPOREAL (EC) BLOOD BEING RETURNED TO THE PATIENT. THE PATIENT REQUIRED A BLOOD TRANSFUSION DUE TO DROP IN HEMOGLOBIN. THREE DAYS AFTER THE EVENT, A NEW SET WAS PLACED AND NO FURTHER ISSUES WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22293171 ↗
• MalfunctionJun 16, 2025Fluid/Blood Leak; Infusion or Flow Problem

  CRRT [CONTINUOUS RENAL REPLACEMENT THERAPY] MACHINE RUNNING WITH A ST150 FILTER. MACHINE ALARMED FOR "BLOOD LEAK IN EFFLUENT". EXAMINED FILTER AND A SIGNIFICANT AMOUNT OF BLOOD WAS IN THE EFFLUENT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211427 ↗
• MalfunctionOct 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A PRISMAFLEX ST150 SET DURING AN UNSPECIFIED PROCESS STEP. 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 20417450 ↗
• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN UNSPECIFIED LOCATION OF A PRISMAFLEX ST150 SET DURING CONTINUOUS RENAL REPLACEMENT 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 20212356 ↗
• MalfunctionSep 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE LEFT BLOOD PUMP AREA OF A PRISMAFLEX ST150 SET DURING CONTINUOUS RENAL REPLACEMENT 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 20148803 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212216. One submission often covers many models, so check the product and lot details in each record.

• Z-1224-2026 · Jan 6, 2026 · Open, Classified
  PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Z-0084-2023 · Sep 14, 2022 · Open, Classified
  Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement th