PrismaflexRecalls & reported problems across all models

We found 4 models of Prismaflex by Gambro AB in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2020 and May 5, 2025 — classified as 3 deaths, 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

8 FDA recall records name at least one of these models by its device identifier, 2 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 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 28, 2021Terminated

   Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

   Z-1279-2021 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

2. Jan 28, 2021Terminated

   Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

   Z-1278-2021 · Root cause: Process control · Recall details · FDA record ↗

3. Feb 6, 2020Terminated

   Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

   Z-1833-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Feb 6, 2020Terminated

   Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

   Z-1832-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Feb 6, 2020Terminated

   Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

   Z-1831-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Feb 6, 2020Terminated

   Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

   Z-1829-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Oct 4, 2019Open, Classified

   Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

   Z-0279-2020 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

8. Oct 4, 2019Open, Classified

   Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

   Z-0277-2020 · Root cause: Software design · Recall details · FDA record ↗

Most reported Prismaflex problems

Prismaflex models

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

• Prismaflex 7.20

  Dialyzer, high permeability with or without sealed dialysate system
  3 recalls1 death8 reports
• Prismaflex 7.XX

  Dialyzer, high permeability with or without sealed dialysate system
  3 recalls2 deaths4 reports
• Prismaflex 5.XX

  Dialyzer, high permeability with or without sealed dialysate system
  3 recalls0 reports
• PRISMAFLEX 7.21

  Dialyzer, high permeability with or without sealed dialysate system
  2 recalls4 reports

Recent Prismaflex adverse event reports

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

• MalfunctionMay 5, 2025Filtration Problem; Protective Measures Problem; Filtration Problem; Protective Measures Problem

  IT AS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX MACHINE AND AN UNKNOWN TYPE OF PRISMAFLEX SET, FOAM WAS OBSERVED IN THE DEAERATION CHAMBER, AND THE MACHINE ALARMED "FILTER CLOTTED". TWO (2) SIMILAR INCIDENTS OCCURRED DURING THE SAME DAY AND IN BOTH EVENTS 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 21964594 ↗
• MalfunctionNov 25, 2024Inadequate Ultra Filtration; Inadequate Ultra Filtration

  IT WAS REPORTED THAT AN EXCESSIVE ULTRAFILTRATION EVENT OCCURRED ON A PRISMAFLEX 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 20774372 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT THE SCREWS ON THE BASE OF A PRISMAFLEX MACHINE WERE OBSERVED TO BE BROKEN DURING AN UNSPECIFIED PROCESS STEP. THE DEVICE WAS AT RISK OF TIPPING OVER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712191 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAFLEX CONTROL UNIT, THE PATIENT EXPERIENCED A CARDIOPULMONARY ARREST. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 15363030 ↗
• MalfunctionJul 27, 2022Device Alarm System; Activation Failure

  CRRT MACHINE ARRIVED ON UNIT AND UPON TURNING ON RN WAS UNABLE TO START DUE TO ALARM ON SCREEN STATING "ROUTINE MAINTENANCE DUE NOW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112063 ↗
• MalfunctionMar 22, 2022No Display/Image

  WHILE THE PATIENT WAS UNDERGOING CRRT, THE MACHINE'S SCREEN THEN TURNED ALL RED. RN UNABLE TO RETURN BLOOD. THERE WAS NO EVIDENCE OF HARM NOTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847993 ↗
• MalfunctionJan 26, 2022Break; Break

  IT WAS REPORTED DURING THE SETUP OF A PRISMAFLEX MACHINE, THE DEVICE BASE WAS OBSERVED TO BE LOOSE WHEN IT CONNECTS TO THE MAIN BODY OF THE MACHINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359485 ↗
• MalfunctionDec 1, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY ON A PEDIATRIC PATIENT USING A PRISMAFLEX CONTROL UNIT AND FOUR (4) UNITS OF A PRISMAFLEX HF20, SELF-TEST FAILURE (4, PRESSURE POD/SENSOR ISSUE) ALARMS WERE GENERATED AND AT LEAST ONE OF THE TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. A BLOOD TRANSFUSION WAS PERFORMED ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 12908797 ↗
• MalfunctionFeb 11, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX MACHINE, THE DEVICE HAD A MISSING BLOOD PUMP CRANK. IT WAS REPORTED THAT BLOOD WAS NOT RETURNED TO THE PATIENT A TOTAL OF THREE TIMES. THE AMOUNT OF BLOOD LOSS WAS NOT REPORTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11315064 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RAPIDLY REOCCURRING "EXCESSIVE TMP" ALARMS WAS GENERATED ON A PRISMAFLEX MACHINE DURING PEDIATRIC CONTINUOUS RENAL REPLACEMENT THERAPY . TREATMENT WAS DISCONTINUED AND BEFORE THE THERAPY WAS RESTARTED, THE PATIENT BECAME BRADYCARDIC AND SEVERELY HYPOTENSIVE. RESUSCITATION FLUIDS WAS PROVIDED. THE PATIENT WAS RECOVERING IN THE INTENSIVE CARE UNIT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 11095344 ↗
• MalfunctionSep 23, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT APPROXIMATELY ONE HOUR INTO CONTINUOUS VENO-VENOUS HEMODIALYSIS USING A PRISMAFLEX CONTROL UNIT AND A PRISMAFLEX M100 SET, A 'MAIN POWER LOST ALARM' WAS GENERATED, FOLLOWED BY A ´MALFUNCTION: VOLTAGE OUT OF RANGE' ALARM. IT WAS REPORTED THAT THE PRISMAFLEX WAS PLUGGED IN SECURELY TO THE RED OUTLET. THE TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL (EC) BLOOD BEING MANUALLY RETURNED TO THE PATIENT AS CLOTS WERE OBSERVED IN THE TUBING. THE AMOUNT OF BLOOD LOSS WAS NOT REPORTED. IT WAS REPORTED THE A BLOOD TRANSFUSION WAS ADMINISTERED TO PATIENT. FURTHER INSPECTION OBSERVED THAT THE PLUG CONNECTING THE POWER CORD TO THE PRISMAFLEX MACHINE INSIDE THE BLACK PLASTIC CONNECTOR WAS NOT ALL THE WAY PLUGGED IN TO THE BACK OF THE MACHINE. THIS WAS CORRECTED AND TREATMENT WAS RE-STARTED WITHOUT FURTHER INCIDENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574908 ↗
• DeathJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX CONTROL UNIT, THE PATIENT PASSED AWAY WHILE CONNECTED TO THE MACHINE. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 10236307 ↗
• MalfunctionApr 21, 2020Break; Break

  IT WAS REPORTED THAT THE WHEEL OF A PRISMAFLEX MACHINE WAS OBSERVED TO BE BROKEN. THIS EVENT HAPPENED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9983837 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ¿SELF-TEST FAILURE, CODE 4¿ ALARM WAS TRIGGERED TWICE AND A TRANSMEMBRANE PRESSURE WAS OBSERVED TO INCREASE DURING CONTINUOUS VENO-VENOUS HEMODIAFILTRATION WITH A PRISMAFLEX CONTROL UNIT AND A PRISMAFLEX SET. TROUBLESHOOTING WAS UNSUCCESSFUL AND THE TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. AS A RESULT, THE PATIENT NEEDED AN EMERGENCY INTUBATION. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9981157 ↗
• DeathMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY, A PATIENT PASSED AWAY WHILE CONNECTED TO A PRISMAFLEX CONTROL UNIT. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 9889236 ↗