Prismaflex 7.20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07332414124236), received between Apr 21, 2020 and May 5, 2025 — classified as 1 death, 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

3 other recalls cover devices cleared under the same FDA submission (K131516); 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 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 · FDA record ↗

2. 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 · FDA record ↗

3. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131516. One submission often covers many models, so check the product and lot details in each record.

• Z-2066-2020 · Apr 7, 2020 · Terminated
  Prismaflex Control Unit
• Z-1926-2018 · Apr 24, 2018 · Terminated
  Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilogram
• Z-1925-2018 · Apr 24, 2018 · Terminated
  Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilogram