NA 7211010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010555960), received between May 16, 2017 and Mar 4, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, ONE (1) DYONICS 25 CONTROL UNIT WAS ON FULL FLOW, DESPITE BEING SET AT 90 MMHG WHILE DOING THE HIP ARTHROSCOPY, THE PATIENT ENDED UP WITH A SEVERE SWOLLEN LEG. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 21516204 ↗
• MalfunctionNov 21, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE CONTROL UNIT DYONICS 25 WAS NOT ABLE TO KEEP THE PRESSURE SETTING. PUMP PRESSURE GOES UP BY ITSELF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751974 ↗
• MalfunctionApr 4, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE DYONICS 25 CONTROL UNIT PRESSURE TRANSDUCERS DIFFERENCE WAS GREATER THAN 5 MMHG. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042632 ↗
• MalfunctionJul 28, 2021Increase in Pressure; Communication or Transmission Problem; Increase in Pressure; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE CONTROL UNIT PRESSURE INCREASED ABOVE SPECIFICATIONS BY ITSELF AND HAD PRESSURE DIFFERENCE READINGS FROM P2 SENSOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12241805 ↗
• MalfunctionMay 19, 2021Communication or Transmission Problem; Pressure Problem; Communication or Transmission Problem; Pressure Problem

  IT WAS REPORTED THAT, DURING SETUP FOR SURGERY, THE "CONTROL UNIT, DYONICS 25" WAS NOT READING THE CARTRIDGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO PROCEDURAL DELAYS AND NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT TRANSDUCER P1 FAILED HIGH PRESSURE TEST WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850043 ↗
• MalfunctionFeb 9, 2021Free or Unrestricted Flow; Pressure Problem; Free or Unrestricted Flow; Pressure Problem

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE DYONICS 25 CONTROL UNIT WAS NOT KEEPING THE PRESSURE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305310 ↗
• MalfunctionSep 1, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE CONTROL UNIT HAD A CASSETTE OFFSET ERROR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10477897 ↗
• MalfunctionAug 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE HAS TRANSDUCER ISSUES. NO BACK UP DEVICE WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7751433 ↗
• MalfunctionMar 27, 2018Increase in Pressure

  IT WAS REPORTED THAT THE SURGEON COMPLAINED ABOUT THE PRESSURE SEEMING MUCH HIGHER THAN THE SETTINGS SHOWED. HE STARTED AT 40MMHG AND FLOW RATE AT 1.5. EVEN WITH THE PUMP SET TO 20MMHG, HE SAID THE WATER WAS SHOOTING EVERYWHERE. NO PATIENT INJURY OR SIGNIFICANT TIME DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7374282 ↗
• MalfunctionMar 14, 2018Calibration Problem

  IT WAS REPORTED THAT THE DEVICE CALIBRATION WAS OFF. THERE WAS NO BACK UP DEVICE AVAILABLE AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337041 ↗
• MalfunctionMar 13, 2018Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS MAKING A LOUD NOISE. THERE WAS NO BACK UP DEVICE AVAILABLE AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7336709 ↗
• MalfunctionMar 2, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THE DEVICE WAS NOT REGULATING PRESSURE, CONSEQUENTLY, IT WAS OVERPUMPING. NO PATIENT INJURIES OR COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7308819 ↗
• MalfunctionFeb 27, 2018Inaccurate Flow Rate; Improper Flow or Infusion

  IT WAS REPORTED THAT THE PUMP WAS RUNNING HIGHER THAN IT SHOULD, THE FLOW RATE KEPT JUMPING UP. NO PATIENT INJURY OR SIGNIFICANT TIME DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7300583 ↗
• MalfunctionFeb 15, 2018Device Emits Odor; Failure to Power Up

  IT WAS REPORTED THAT THE DEVICE WAS NOT TURNING ON AND IT HAD A BURNING SMELL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7273430 ↗
• MalfunctionJan 12, 2018Pressure Problem

  IT WAS REPORTED THAT PRESSURE MONITOR SEEMS OFF, BUT FLUID PUMPED IN IS TOO HIGH. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7185833 ↗
• MalfunctionJan 4, 2018Device Operates Differently Than Expected

  THE DEVICE WILL NOT HOLD CARTRIDGES ON ITS OWN, SOMEONE HAS TO PHYSICALLY HOLD CARTRIDGE IN FOR DURATION OF CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7163655 ↗
• MalfunctionNov 25, 2017Sticking

  IT WAS REPORTED THAT THE ON/OFF BUTTON STUCK, THE DEVICE HAD TO UNPLUG TO TURN OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7058013 ↗
• MalfunctionOct 23, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CONTROLLER WAS NOT OPERATING PROPERLY, ISSUES WITH HIGH FLOW RATE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6969720 ↗
• MalfunctionOct 6, 2017Device Displays Incorrect Message

  IT WAS REPORTED THAT THE DEVICE WAS FAILED TO START WITH AN ERROR MESSAGE OF SYSTEM ERROR. THE PROBLEM OCCURRED DURING PREPARATION OF THE SURGERY. THE PROCEDURE WAS COMPLETED WITH A BACK-UP COMPETITOR DEVICE.

  Patient problems: No Information

  MAUDE report 6921501 ↗
• MalfunctionSep 20, 2017Pressure Problem

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE DEVICE WAS NOT KEEPING UP PRESSURE. DISTENSION WAS LOST WHILE INSTRUMENTATION WAS INSIDE OF THE PATIENT. NO INJURIES WERE REPORTED. A BACKUP SNN DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6881515 ↗
• MalfunctionSep 15, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THE DEVICE GENERATED TOO MUCH FLUID DURING A KNEE PROCEDURE. NO INJURIES OR COMPLICATIONS WERE REPORTED AS A RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868343 ↗
• MalfunctionSep 14, 2017Smoking

  IT WAS REPORTED THE CONTROL UNIT WAS SMOKING. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865411 ↗
• MalfunctionMay 16, 2017Increase in Pressure; Device Operates Differently Than Expected

  IT WAS REPORTED THE DYONICS 25 CONTROL UNIT WAS CAUSING OVERPRESSURIZATION OF FLUID DURING AN ACL PROCEDURE. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6570646 ↗