NA 7211004Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 03596010543561), received between May 3, 2018 and Jun 30, 2025 — classified as 4 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT, DURING SURGERY, TWO (2) DYONICS 25 INFLOW TUBES WERE NOT MAINTAINING PRESSURE, WITH LOW PRESSURE AND HIGH FLOW. SURGERY WAS COMPLETED WITH THE SAME DEVICES. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22353162 ↗
• MalfunctionFeb 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN CHECKING THE GOOD AT THE WAREHOUSE, TWO (2) DYONICS 25 TUBE SETS FROM THE SAME BOX HAD THE STERILE FILM SEPARATED FROM THE BOX. THE STERILIZE SEAL WAS COMPLETELY DETACHED FROM THE BOX, AND THERE WAS NO SIGN OF GLUE ON THE SURFACE OF THE BOXES. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445477 ↗
• MalfunctionFeb 18, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING SURGERY, TWO (2) CASSETTES OF THE DYONICS 25 INFLOW SET TRANSDUCER DID NOT LINE UP, RESULTING IN A HIGH FLOW RATE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402871 ↗
• MalfunctionFeb 10, 2025Delivered as Unsterile Product; Material Integrity Problem; Delivered as Unsterile Product; Material Integrity Problem

  IT WAS REPORTED THAT THE DYONICS 25 TUBE SET WAS DAMAGED, AFFECTING THE STERILE BARRIER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349210 ↗
• MalfunctionDec 7, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE INVOLVING AN INFLOW ONLY TUBE SET, THE PUMP FLUID LEAKED INTO THE JOINT. IT APPEARED THAT THE CANNULA AND OBTURATOR'S SHEATH WAS BROKEN, BUT THE FLUID WAS ACTUALLY SHOOTING OUT OF THE SKIN INCISION/PORTAL WHERE THE SHEATH WAS LOCATED. THE PRESSURE WAS REDUCED TO 35, AND A REPLACEMENT PUMP WAS BROUGHT IN BUT NOT USED, AS FLUID HAD ALREADY SPREAD INTO THE PATIENT'S LEG. UPON REMOVING THE DRAPING, APPROXIMATELY 2L OF FLUID WAS FOUND IN THE THIGH. THIS EXTENSIVE FLUID EXTRAVASATION LED TO SEVERE SWELLING, CAUSING TRAUMATIC INJURY TO NERVES AND TISSUES. THE PROCEDURE WAS CANCELLED DUE TO THE SURGEON'S CONCERNS ABOUT POTENTIAL COMPARTMENT SYNDROME AND PATIENT SAFETY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION BUT NEEDED 5.5 HOURS OF MONITORING IN THE RECOVERY ROOM. AS OF NOW, THE PATIENT HAS NOT RECOVERED SUFFICIENTLY TO RESCHEDULE THE PROCEDURE.

  Patient problems: Extravasation; Insufficient Information; Nerve Damage

  MAUDE report 18286148 ↗
• MalfunctionJun 13, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DYONICS 25 PUMP WAS SET TO A PRESSURE OF 15 MMHG BUT WAS STILL RUNNING AT WHAT FELT LIKE A VERY HIGH PRESSURE, LIKE 60MMHG, AND THE PATIENT'S SHOULDER WAS SWELLING FASTER THAN ANTICIPATED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 17119400 ↗
• MalfunctionSep 12, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE FLUID OF THE DYONICS INFLOW TUBE DID NOT FLOW OR THE PUMP WAS OVERPUMPING FLUID. ALSO, "WRONG/NO INSTRUMENT" ERROR WAS ALSO OCCASIONALLY DISPLAYED. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. FURTHER DETAILS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403290 ↗
• MalfunctionSep 12, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, DURING A KNEE PROCEDURE, THE DYONICS INFLOW TUBE OVERPRESSURED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15399835 ↗
• MalfunctionSep 10, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE DYONICS INFLOW TUBE OVERPRESSURED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397619 ↗
• MalfunctionAug 29, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE DYONICS 25 FLUID MANAGEMENT SYSTEM PUMP RAN AT AN ELEVATED FLOW RATE AND WAS UNRESPONSIVE TO CONTROL. THE PROBLEM WAS NOTICED DURING SET UP, A 5 MINUTES DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316162 ↗
• MalfunctionAug 29, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PUMP OF THE DYONICS 25 FLUID MANAGEMENT SYSTEM RAN AT AN ELEVATED FLOW RATE AND WAS UNRESPONSIVE TO CONTROL. THE PROBLEM WAS NOTICED DURING SET UP, A 5 MINUTES DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316011 ↗
• MalfunctionMay 23, 2022Increase in Pressure; Connection Problem; Increase in Pressure; Connection Problem

  IT WAS REPORTED THAT, DURING A ACL SURGERY, THREE (3) DYONICS 25 CARTRIDGE TUBING SETS WERE NOT SITTING PROPERLY IN THE PUMP SO THE PUMP IS OVER PUMPING FLUID. THE CARTRIDGE COULD BE MANUALLY PUSHED IN FURTHER TO SOLVE THE ISSUE BUT CAME BACK OUT AS SOON AS IT IS NOT BEING PUSHED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14478615 ↗
• MalfunctionMay 23, 2022Increase in Pressure; Connection Problem; Increase in Pressure; Connection Problem

  IT WAS REPORTED THAT, DURING A ACL SURGERY, THREE (3) DYONICS 25 CARTRIDGE TUBING SETS WERE NOT SITTING PROPERLY IN THE PUMP SO THE PUMP IS OVER PUMPING FLUID. THE CARTRIDGE COULD BE MANUALLY PUSHED IN FURTHER TO SOLVE THE ISSUE BUT CAME BACK OUT AS SOON AS IT IS NOT BEING PUSHED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14478608 ↗
• MalfunctionMay 20, 2022Excess Flow or Over-Infusion; Connection Problem; Excess Flow or Over-Infusion; Connection Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE 'DYONICS TUBE SET' WAS NOT SITTING PROPERLY INTO THE PUMP SO THE PUMP WAS OVER PUMPING FLUID, THE CARTRIDGE COULD BE MANUALLY PUSHED IN FURTHER TO SOLVE THE ISSUE, BUT IT COMES BACK OUT AS SOON AS IT WAS LET GO. THIS RESULTED IN A NON-SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14456779 ↗
• MalfunctionApr 4, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THREE DYONICS INFLOW TUBE SET HAD THE SAME FAILURE. THE PUMP CARTRIDGE DID NOT FIT IN PROPERLY IN THE PUMP, CAUSING THE PUMP TO READ INCORRECTLY THE PRESSURE AND PUMP WATER CONTINUOUSLY. THE ISSUE WAS STOPPED WHEN THE CARTRIDGE WAS MANUALLY HELD IN PLACE. THE PROCEDURE WAS COMPLETED WITH LESS THAN 10 MINUTES OF DELAY FOR EACH CHANGE USING A BACK-UP DEVICE. IT IS UNKNOWN WHEN THE EVENT OCCURRED RELATIVE TO SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14006586 ↗
• MalfunctionApr 4, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THREE DYONICS INFLOW TUBE SET HAD THE SAME FAILURE. THE PUMP CARTRIDGE DID NOT FIT IN PROPERLY IN THE PUMP, CAUSING THE PUMP TO READ INCORRECTLY THE PRESSURE AND PUMP WATER CONTINUOUSLY. THE ISSUE WAS STOPPED WHEN THE CARTRIDGE WAS MANUALLY HELD IN PLACE. THE PROCEDURE WAS COMPLETED WITH LESS THAN 10 MINUTES OF DELAY FOR EACH CHANGE USING A BACK-UP DEVICE. IT IS UNKNOWN WHEN THE EVENT OCCURRED RELATIVE TO SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14006585 ↗
• MalfunctionApr 4, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THREE DYONICS INFLOW TUBE SET HAD THE SAME FAILURE. THE PUMP CARTRIDGE DID NOT FIT IN PROPERLY IN THE PUMP, CAUSING THE PUMP TO READ INCORRECTLY THE PRESSURE AND PUMP WATER CONTINUOUSLY. THE ISSUE WAS STOPPED WHEN THE CARTRIDGE WAS MANUALLY HELD IN PLACE. THE PROCEDURE WAS COMPLETED WITH LESS THAN 10 MINUTES OF DELAY FOR EACH CHANGE USING A BACK-UP DEVICE. IT IS UNKNOWN WHEN THE EVENT OCCURRED RELATIVE TO SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14006583 ↗
• MalfunctionFeb 16, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DYONICS INFLOW TUBE SET HAD ISSUES SITTING IN THE PUMP PROPERLY. THE FLUID WAS FLOWING VERY FAST AND COULD NOT BE PROPERLY ADJUSTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544229 ↗
• MalfunctionFeb 16, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DYONICS INFLOW TUBE SET HAD ISSUES SITTING IN THE PUMP PROPERLY. THE FLUID WAS FLOWING VERY FAST AND COULD NOT BE PROPERLY ADJUSTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544180 ↗
• InjuryJan 26, 2022Infusion or Flow Problem; Noise, Audible; Infusion or Flow Problem; Noise, Audible

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHEN THE 'DYONICS 25 INFLOW TUBE' WAS PLUGGED-IN INTO THE PUMP, IT MADE A NOISE, THE PUMP WAS NOT PRIMING CORRECTLY AND CAUSED INFLAMMATION IN THE PATIENT'S JOINT AT THE BEGINNING OF THE CASE, BUT IT WAS QUICKLY FIXED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation

  MAUDE report 13361225 ↗
• MalfunctionNov 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE INSTRUMENTS OUTSIDE PATIENT, THERE WAS A FLUID LEAKED FROM THE DYONICS 25 CASSETTE. THE CASSETTE WAS MISSING THE TRANSDUCER MEMBRANE AND THE MAIN BODY OF THE PUMP BROKE DOWN DUE TO THE FLUID LEAKAGE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. A SIGNIFICANT DELAY WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750523 ↗
• MalfunctionAug 18, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, A SERUM LEAK WAS NOTICED WHEN CONNECTING TO THE DYONICS TUBE SET. A 2-HOUR SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340128 ↗
• MalfunctionMay 24, 2021Leak/Splash; Component Missing; Leak/Splash; Component Missing

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, FLUID LEAKED FROM THE CASSETTE IN THE DYONICS 25 INFLOW ONLY TUBE SET (3). A BACKUP DEVICE AVAILABLE, NO DELAY, NO PATIENT INJURY WAS REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD MISSING MEMBRANES WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870061 ↗
• MalfunctionApr 28, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR PROCEDURE, STAFF FOUND A HAIR MIXED AND ENCLOSED IN THE STERILIZATION TRAY WHEN THE PACKAGE OF THE DYONICS 25 INFLOW ONLY TUBE SET WAS OPENED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. 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 11737192 ↗
• InjuryMar 25, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING A MPFL REPAIR THE DYONICS FLOW RATE DROPPED AFTER 15 MINUTES OF USE. THE SCREEN ON THE DYONICS 25 MACHINE SHOWED 1.5 L/M IN THE FIRST 15 MINUTES AND THEN DROPPED TO 0.3L/M AFTER THAT. THEN THE CLINICAL SUPPORT TEAM TRIED RESTARTING THE MACHINE AND GOT THE SAME RESULT. THE ISSUE WAS COMPLETED WITH A SALINE BOTTLE USING GRAVITY AND A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO 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 11571646 ↗