PRISMAFLEX SET HF1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 07332414069254), received between Jan 3, 2018 and Feb 18, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (25 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 other recalls cover devices cleared under the same FDA submission (K042938); 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-1229-2026 · Root cause: Component design/selection · FDA record ↗

2. Sep 14, 2022Open, Classified

   Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

   Z-0083-2023 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Crack

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFEX HF1000 SET, THE "EFFLUENT TUBING ON FILTER NOTED TO BE CRACKED AT LURE LOCK, WITH PARTIAL CRACKING NOTED AT EFFLUENT TUBING". 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 24381637 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID LEAKAGE WAS OBSERVED DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX HF1000 SET, DESCRIBED AS "THE UPPER RIGHT OF THE CIRCUIT HAD LIQUID COME INTO THE DE-AERATION PORTION." THE SET 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 24170310 ↗
• MalfunctionNov 26, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING CONTINUOUS VENOVENOUS HEMOFILTRATION WITH A PRISMAFLEX HF 1000 SET, THE ACCESS LINE DID NOT FIT SECURELY ONTO THE PATIENT'S CATHETER AND AIR WAS OBSERVED IN THE ACCESS LINE AND FILTER. TREATMENT WAS DISCONTINUED AND THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT. 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 23660407 ↗
• MalfunctionSep 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A "BLACK SUBSTANCE¿ WAS OBSERVED ON THE EFFLUENT TUBING OF A PRISMAFLEX HF1000 SET PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032003 ↗
• MalfunctionAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY USING OF A PRISMAFLEX HF 1000 SET, ¿THE STOP COCK AND CONNECTION TO THE EPO SYRINGE WAS CRACKED" AND LEAKED BLOOD. 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 22811201 ↗
• MalfunctionMar 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCESS STEP OF THERAPY, A PRISMAFLEX HF SET WAS OBSERVED WITH "A PIECE THAT HAS BEEN LEAKING AFTER RUNNING CAUSING BLOOD TO BACK UP AND THE NEED FOR RESTART THERAPY". ACCORDING TO THE REPORTER THERE WERE 12 UNITS IN THEIR STOREROOM. 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 21724992 ↗
• MalfunctionDec 13, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT "AIR STARTED PULLING INTO CIRCUIT FROM THE CONNECTION OF THE PBP TO THE ACCESS" OF THREE (3) PRISMAFLEX HF1000 SETS DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE PATIENT "LOST 3 FILTERS". THE ACTUAL VOLUME OF BLOOD LOSS WAS NOT KNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925659 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "LEAKING WAS NOTED AROUND THE FLUID PUMP AREA" DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX HF 1000 SET. THE PATIENT "LOST A CIRCUIT OF BLOOD". 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 20925545 ↗
• MalfunctionNov 26, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A CRACK BELOW THE FILTER OF A PRISMAFLEX HF1000 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20781880 ↗
• MalfunctionOct 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD BACKED UP INTO THE SYRINGE LINE OF A PRISMAFLEX HF1000 SET AND LEAKED DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THERE WAS NOT REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545639 ↗
• MalfunctionOct 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE FILTER OF A PRISMAFLEX HF1000 SET DURING HEMODIALYSIS THERAPY. 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 20545154 ↗
• MalfunctionOct 25, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE RETURN LINE OF A PRISMAFLEX HF1000 SET WAS OBSERVED TO BE CLOTTED/CLOGGED WITH CLEAR PLASTIC DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE MACHINE ALARMED "FLOW OBSTRUCTION". 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 20535272 ↗
• MalfunctionMar 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED WHERE THE EFFLUENT LINE EXITS THE CARTRIDGE OF A PRISMAFLEX HF1000 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934712 ↗
• MalfunctionDec 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A BLOOD LEAK WAS OBSERVED ORIGINATING FROM THREE DIFFERENT LOCATIONS AFTER THE FILTER ON RED LINE OF A PRISMAFLEX HF1000 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE EXTRACORPOREAL BLOOD WAS NOT RETURNED, AND THE SET WAS REPLACED. THE VOLUME OF BLOOD LOSS WAS NOT REPORTED. 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 18371746 ↗
• MalfunctionDec 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS A BLOOD LEAK/COAGULATED BLOOD WAS OBSERVED ORIGINATING FROM THE LUER CONNECTION BETWEEN THE PRISMAFLEX HF1000 SET AND THE THERMAX BLOOD WARMER DISPOSABLE DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE BLOOD REMAINED COAGULATED AROUND THE CONNECTION SITE AND NO BLOOD WAS NOTED ON THE FLOOR. THE VOLUME OF BLOOD LOSS WAS NOT REPORTED. 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 18291485 ↗
• MalfunctionDec 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A BLOOD LEAK/COAGULATED BLOOD WAS OBSERVED ORIGINATING FROM THE LUER CONNECTION BETWEEN THE PRISMAFLEX HF1000 SET AND THE THERMAX BLOOD WARMER DISPOSABLE DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE BLOOD REMAINED COAGULATED AROUND THE CONNECTION SITE AND NO BLOOD WAS NOTED ON THE FLOOR. THE VOLUME OF BLOOD LOSS WAS NOT REPORTED. 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 18276715 ↗
• MalfunctionOct 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A BLOOD LEAK/CLOT WAS OBSERVED ORIGINATING FROM THE LUER CONNECTION BETWEEN THE PRISMAFLEX HF 1000 SET AND A THERMAX DISPOSABLE SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE CLOT WAS NOTED TO BE SURROUNDING THE TOP OF THE FILTER. THE AMOUNT OF BLOOD LOSS WAS NOT REPORTED. 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 17962513 ↗
• MalfunctionApr 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL LEAK WAS OBSERVED ORIGINATING FROM THE BLOOD PUMP OF A PRISMAFLEX HF1000 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709389 ↗
• MalfunctionNov 22, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH ONE UNIT OF PRISMAFLEX HF1000, THE ARTERIAL LUER CONNECTOR WAS OBSERVED TO BE CRACKED AND A BLOOD LEAK OCCURRED. 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 15841114 ↗
• MalfunctionJun 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WITHIN A FEW HOURS OF STARTING THERAPY WITH A PRISMAFLEX HF1000 SET, AN EXTERNAL BLOOD LEAK WAS OBSERVED. THE EXTRACORPOREAL (EC) BLOOD WAS RETURNED TO THE PATIENT AND FILTER WAS CHANGED. 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 14644911 ↗
• MalfunctionMar 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX (B)(4) , A LARGE AMOUNT OF BLOOD WAS OBSERVED TO BE LEAKING OUT OF THE CENTRAL ROLLER CLAMP AREA UNDER THE HOUSING. TREATMENT WAS DISCONTINUED. 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 13656365 ↗
• MalfunctionJan 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING WITH A PRISMAFLEX HF1000 SET, AN EXTERNAL FLUID LEAKAGE WAS OBSERVED FROM THE STATIC DISCHARGE RING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314066 ↗
• MalfunctionOct 18, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX HF1000 SET, ¿HIGH ACCESS PRESSURE, FILTER PRESSURES 300, AIR BUBBLES IN FILTER LINE, AND DEAERATION CHAMBER¿ ALARMS WERE GENERATED AND TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE EVENT OCCURRED THREE (3) TIMES AND THE ¿TUBING CONNECTORS WERE NOT CONNECTED CORRECTLY ON THE TUBING¿. 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 12647612 ↗
• MalfunctionOct 18, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX HF1000 SET, ¿HIGH ACCESS PRESSURE, FILTER PRESSURES 300, AIR BUBBLES IN FILTER LINE, AND DEAERATION CHAMBER¿ ALARMS WERE GENERATED AND TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE EVENT OCCURRED TWICE AND THE ¿TUBING CONNECTORS WERE NOT CONNECTED CORRECTLY ON THE TUBING¿. 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 12647529 ↗
• MalfunctionOct 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX HF1000 SET, AN EXTERNAL BLOOD LEAK WAS OBSERVED. THE LEAK WAS FURTHER SPECIFIED AS A FEW DROPS AT THE TOP EDGE OF THE FILTER. AN UNSPECIFIED TYPE OF BLOOD LEAK TEST WAS PERFORMED AND THE RESULT WAS POSITIVE FOR A SMALL AMOUNT OF BLOOD LEAK. THE BLOOD WAS RETURNED, AND A NEW FILTER WAS PRIMED AND TREATMENT WAS RESTARTED. IT WAS REPORTED THE PATIENT TOLERATED THE BLOOD RETURN AND INITIATION OF TREATMENT WENT WELL. 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 12624737 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042938. One submission often covers many models, so check the product and lot details in each record.

• Z-1230-2026 · Jan 6, 2026 · Open, Classified
  PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Z-0085-2023 · Sep 14, 2022 · Open, Classified
  Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
• Z-2379-2021 · Jul 22, 2021 · Terminated
  Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
• Z-2205-2014 · Jul 18, 2014 · Terminated
  Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Z-2204-2014 · Jul 18, 2014 · Terminated
  Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box