NA 7211006Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010543592), received between Aug 24, 2017 and Dec 31, 2025 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (8 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.

• MalfunctionDec 31, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THERE WAS CONTINUOUS BACK FLOW FROM A DYONICS INFLOW/OUTFLOW FORK SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934944 ↗
• MalfunctionNov 3, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE DYONICS INFLOW/OUTFLOW HAD AN EXCESS FLOW AS THE NUMBER 60 WAS ABNORMALLY DISPLAYED ON THE SCREEN REGARDLESS THAT THE NORMAL SETTING WAS 30. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459877 ↗
• MalfunctionJun 18, 2025Device Alarm System; Increase in Pressure; Noise, Audible; Device Alarm System; Increase in Pressure; Noise, Audible

  IT WAS REPORTED THAT DURING SETUP, WHEN THE DYONICS 25 INFLOW/OUTFLOW FORK SUCTION WAS CONNECTED TO THE CONTROLLER, THE PRESSURE BUILT UP TO 999 MMHG AND AN "OVER PRESSURE" ALARM WAS TRIGGERED. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE, AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286996 ↗
• MalfunctionNov 11, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE DYONICS 25 INFLOW/OUTFLOW FORK SUCTION STARTED TO HAVE A LOT OF BACK FLOW COMING THROUGH. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658385 ↗
• MalfunctionOct 7, 2024Leak/Splash; Increase in Pressure; Leak/Splash; Increase in Pressure

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE PIPE WAS BEING PURGED, THE CONSOLE REGARDED VERY HIGH PRESSURES AND WAS IMMEDIATELY LOWED TO ZERO WITHOUT THE SALINE SUCTION COMING THROUGH THE DYONICS 25 INFLOW/OUTFLOW, THERE WAS A LEAK IN THE CASSETTE GASKETS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391692 ↗
• MalfunctionMay 11, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING AN ACL, A DYONICS 25 INFLOW/OUTFLOW FORK SUCTION WAS OVER PUMPING FLUID. SURGERY CONTINUED WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914958 ↗
• MalfunctionNov 29, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR, A DYONICS 25´S PUMP PRESSURE WAS SET ON 20 PER PHYSICIAN´S REQUEST, HOWEVER THE PUMP PRESSURE RECEIVED WAS BEYOND THE ONE THAT WAS SET, EVENT AFTER BEING SET IN THE LOWEST SETTING. SURGERY WAS COMPLETED WITH THE SAME DEVICE WITH A HEAVY PRESSURE THROUGHOUT THE CASE, WITH A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875881 ↗
• InjuryMar 10, 2022Excess Flow or Over-Infusion; Increase in Pressure; Excess Flow or Over-Infusion; Increase in Pressure

  IT WAS REPORTED THAT DURING SURGERY, THE DYONICS 25 PUMP AND/OR DYONICS 25 TUBING RAN FLUID CONTINUOUSLY AND DID NOT SENSE BACK PRESSURE. IT FILLED THE PATIENTS QUAD FULL OF FLUID. THE SURGEON WAS ABLE TO CATCH THE ISSUE AND STOP THE PUMP. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE AND IF A DELAY OCCURRED. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13719868 ↗
• MalfunctionMar 8, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING USE IN A SHOULDER ARTHROSCOPY, THE "DYONICS 25 INFLOW/OUTFLOW FORK SUCTION" WAS OVER PRESSURIZING THE SHOULDER JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690266 ↗
• InjuryMar 8, 2022Electrical /Electronic Property Problem; Excess Flow or Over-Infusion; Electrical /Electronic Property Problem; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING SURGERY, THE DYONICS 25 PUMP AND/OR DYONICS 25 TUBING RAN FLUID CONTINUOUSLY AND DID NOT SENSE BACK PRESSURE. IT FILLED THE PATIENTS QUAD FULL OF FLUID. THE SURGEON WAS ABLE TO CATCH THE ISSUE AND STOP THE PUMP. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE AND IF A DELAY OCCURRED. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13689097 ↗
• InjuryMar 1, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING SURGERY, THE DYONICS 25 PUMP AND/OR DYONICS 25 TUBING RAN FLUID CONTINUOUSLY AND DID NOT SENSE BACK PRESSURE. IT FILLED THE PATIENTS QUAD FULL OF FLUID. THE SURGEON WAS ABLE TO CATCH THE ISSUE AND STOP THE PUMP. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAYS USING A BACK-UP DEVICE THAT WENT TO GRAVITY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Infiltration into Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635255 ↗
• MalfunctionMar 15, 2021No Flow; No Flow

  IT WAS REPORTED THAT DURING A SURGERY, THE DYONICS INFLOW/OUTFLOW FORK SUCTION WAS NOT DELIVERING PERFUSION FLUID TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SIGNIFICANT DELAY. NO PATIENT INJURY OR 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 11489446 ↗
• MalfunctionOct 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE SURGERY THERE WAS A FLUID LEAK FROM THE CASSETTE BECAUSE THE TRANSDUCER MEMBRANE WAS MISSING. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 10712940 ↗
• InjuryOct 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE SURGERY THE DYONICS 25 INFLOW WAS POWERED ON WITHOUT ANY FAULT. WHEN THE DYONICS TUBING CASSETTE WAS CONNECTED, THE FLUID WAS OPENED TO PRIME THE TUBING AND THE WATER STARTED TO GUSHING OUT OF THE CASSETTE AND THERE WAS AN ERROR STATING " CASSETTE ERROR". THE CASSETTE WAS CHECKED AND IT WAS NOTICED A LEAKING OF WATER IN THE SENSOR REGION. NO PATIENT INJURIES OR SIGNIFICANT DELAY WAS REPORTED. COMPETITOR DEVICE WAS USED TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10704578 ↗
• MalfunctionSep 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING SURGERY, THERE WAS A FLUID LEAKED FROM THE CASSETTE BECAUSE THE TRANSDUCER MEMBRANE WAS MISSING. A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURY. 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 10507073 ↗
• MalfunctionSep 4, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE INFLOW/OUTFLOW FORK SUCTION THE TRANSDUCER MEMBRANES WERE MISSING. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; NO DELAY, BACKUP DEVICE AVAILABLE. NO 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 10495023 ↗
• MalfunctionSep 2, 2020Contamination; Contamination

  IT WAS REPORTED THAT DURING SETUP FOR AN ARTHROSCOPY A PIECE OF HAIR WAS FOUND INSIDE THE STERILE PACKAGE WHEN OPENING IT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR PATIENT 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 Patient Involvement

  MAUDE report 10483898 ↗
• InjuryApr 28, 2020Excess Flow or Over-Infusion; Increase in Pressure; Excess Flow or Over-Infusion; Increase in Pressure

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AND AN ANTERIOR CRUCIATE LIGAMENT THE DYONICS 25 WAS SHOWING HIGH-PRESSURE LEVELS, THE DEVICE WAS IRRIGATING MORE SOLUTION THAN THE NORMAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY BY USING GRAVITY. 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 10003801 ↗
• InjuryApr 28, 2020Excess Flow or Over-Infusion; Increase in Pressure; Excess Flow or Over-Infusion; Increase in Pressure

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AND AN ANTERIOR CRUCIATE LIGAMENT THE DYONICS 25 WAS SHOWING HIGH-PRESSURE LEVELS, THE DEVICE WAS IRRIGATING MORE SOLUTION THAN THE NORMAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY BY USING GRAVITY. 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 10003800 ↗
• MalfunctionMar 2, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS NOTICED THAT THERE WAS NOT STERILIZATION POUCH FOR REMOTE CONTROL IN THE TUBE PACKAGE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME 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 9773093 ↗
• MalfunctionNov 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS NO FLOW DURING SHOULDER ARTHROSCOPY, SO THE JOINT WASN¿T DISTENDING WHICH IMPEDED VISUALIZING THE SUBACROMIAL SPACE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE WITH 20 MINUTES OF DELAY AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9321785 ↗
• MalfunctionFeb 14, 2019Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT WHEN THE DEVICE WAS OPENED AND CONNECTED IT DID NOT WORK, IN ORDER TO COMPLETE THE PROCEDURE THE SURGEON USE A BACKUP COMPETITOR DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ATTEMPTS WERE MADE TO RETRIEVE FURTHER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342062 ↗
• MalfunctionAug 24, 2017Fluid/Blood Leak; Loss of Power; Device Displays Incorrect Message

  IT WAS REPORTED THAT WHEN A BRAND NEW CASSETTE WAS INSTALLED INTO A CONTROL UNIT AND THE IRRIGATION WAS STARTED, THE FLUID LEAKED FROM THE CASSETTE AND THE CONTROL UNIT HAD A POWER DOWN AFTER DISPLAYING ERROR MESSAGE. THEY HAD TO USE A GRAVITY INFLOW WITHOUT USING THE CONTROL UNIT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816058 ↗