PRISMAFLEX SETRecalls & reported problems across all models

We found 8 models of PRISMAFLEX SET by Gambro Industries in the FDA's device registry (GUDID). Together they are named in 334 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2018 and Sep 30, 2026 — classified as 4 deaths, 16 injuries, 314 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (221 reports).

9 FDA recall records name at least one of these models by its device identifier, 9 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PRISMAFLEX SET recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 6, 2026Open, Classified

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

   Z-1230-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. Jan 6, 2026Open, Classified

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

   Z-1228-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

4. Jan 6, 2026Open, Classified

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

   Z-1227-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

5. 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 · Recall details · FDA record ↗

6. Jan 6, 2026Open, Classified

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

   Z-1224-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

7. 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 · names 2 of these models · Recall details · FDA record ↗

8. 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-0082-2023 · Root cause: Error in labeling · Recall details · FDA record ↗

9. 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-0081-2023 · Root cause: Error in labeling · names 2 of these models · Recall details · FDA record ↗

Most reported PRISMAFLEX SET problems

PRISMAFLEX SET models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PRISMAFLEX SET M100

  Dialyzer, high permeability with or without sealed dialysate system
  2 recalls1 death150 reports
• PRISMAFLEX SET M150

  Dialyzer, high permeability with or without sealed dialysate system
  2 recalls1 death66 reports
• PRISMAFLEX SET HF1000

  Dialyzer, high permeability with or without sealed dialysate system
  2 recalls41 reports
• PRISMAFLEX SET HF1400

  Dialyzer, high permeability with or without sealed dialysate system
  2 recalls2 deaths32 reports
• PRISMAFLEX SET 107640US

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall26 reports
• PRISMAFLEX SET 107636US

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall9 reports
• PRISMAFLEX SET M60

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall9 reports
• PRISMAFLEX SET 107643US

  Dialyzer, high permeability with or without sealed dialysate system
  1 report

Recent PRISMAFLEX SET adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately fifteen (15) minutes after initiation of continuous renal replacement therapy (CRRT) using Prismaflex HF set, a patient experienced severe hypotension requiring up to three (3) vasopressors. Anallergic reaction was suspected. After switching to Prismaflex ST set, the hypotensive episodes reportedly did not recur. It is further reported that the patient passed away, however, the date and cause of death were not provided. No additional information is available.

  Patient problems: Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension

  MAUDE report 50951729 ↗
• MalfunctionAug 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303544 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237731 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50210942 ↗
• MalfunctionAug 6, 2026Obstruction of Flow

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

  MAUDE report 50160442 ↗
• MalfunctionAug 3, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50118813 ↗
• MalfunctionJun 29, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH TWO (2) UNSPECIFIED TYPES OF PRISMAFLEX SETS, AN EXTERNAL FLUID LEAK WAS OBSERVED, DESCRIBED AS "THE EFFLUENT DRAINAGE LINE THAT HAD SEPARATED AT POD CAUSING THE FLUID LEAK." THE FIRST THERAPY WAS DISCONTINUED AND THE EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT. THE SET WAS REPLACED TO CONTINUE TREATMENT, AND THE SECOND SET LEAK WAS NOTED. CRRT WAS NOT RESTARTED. 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 25658073 ↗
• MalfunctionJun 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE EFFLUENT BAG OF A PRISMAFLEX M100 SET APPROXIMATELY THIRTY MINUTES AFTER THE START OF CONTINUOUS RENAL REPLACEMENT THERAPY. THE BAG 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 25580108 ↗
• MalfunctionJun 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE REPLACEMENT LINE OF A PRISMAFLEX M100 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447456 ↗
• 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 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A PRISMAFLEX M100 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125119 ↗
• 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 ↗
• MalfunctionMay 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERNAL BLOOD LEAK WAS OBSERVED DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH FOUR (4) PRISMAFLEX HF 1400 SETS, WHICH "AFFECTED ONE PATIENT". THE SET WAS REPLACED TO CONTINUE TREATMENT WITH A SET FROM A DIFFERENT PRODUCT LOT. NO INFORMATION WAS PROVIDED TO CONFIRM WHETHER THE EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT. 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 25072349 ↗