NA 7211010Recalls & reported problems

Summary

The FDA's MAUDE database contains 214 adverse event reports that list this exact device (DI 03596010543554), received between Nov 27, 2017 and Apr 20, 2026 — classified as 24 injuries, 190 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (79 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 25 most recent of 214 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, BEFORE A SHOULDER ARTHROSCOPY, IT WAS NOTICED THAT A DYONICS CONTROL UNIT WAS VERY STRONG, IT WAS SET TO MINIMUM BUT SPRAYING THE SOLUTION VERY FAR. THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923974 ↗
• MalfunctionApr 13, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, A DYONICS CONTROL UNIT WAS SET TO 30 AND THE WATER WAS FLOWING STRONGER THAN EXPECTED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858740 ↗
• MalfunctionApr 8, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE FLOW OF ONE (1) DYONICS 25 CONTROL UNIT WAS NOT CALIBRATED. THE DEVICE DID NOT COMMAND OR REGULATE THE FLOW ACCORDING TO WHAT WAS SHOWN ON THE SCREEN; IT FLOWED STRONGLY, EVEN WHEN THE DEVICE WAS IN THE LOW FLOW. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824433 ↗
• MalfunctionMar 24, 2026Leak/Splash; Increase in Pressure; Air/Gas in Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE CONTROL UNIT, DYONICS 25 MALFUNCTIONED AT THE START OF THE SURGERY; IT WAS OUT OF CONTROL, LEAKING A LOT OF SALINE SOLUTION. IN THE FIRST 10 MINUTES OF THE SURGERY, 12 X 1000ML SALINE SOLUTIONS HAD ALREADY BEEN USED. THE PRESSURE WAS LOWERED TO 20, BUT IT WAS SO STRONG IT FELT LIKE 80. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675867 ↗
• MalfunctionMar 7, 2026No Display/Image

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR ARTHROSCOPY, THE SCREEN OF ONE (1) DYONICS 25 CONTROL UNIT BEGAN FLICKERING, AND THEN SHUT OFF. IT CONTINUED DELIVERING FLUID BUT THE SCREEN WAS COMPLETELY BLACK. IT WAS RESTARTED WITH THE SAME RESULT. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541656 ↗
• MalfunctionMar 7, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, ONE (1) DYONICS 25 CONTROL UNIT WAS RELEASING MORE SALINE SOLUTION THAN IT SHOULD HAD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541222 ↗
• MalfunctionMar 2, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE SURGEON COMPLAINED THAT ONE (1) DYONICS 25 CONTROL UNIT WAS OUT OF CALIBRATION. EVEN AFTER TURNING THE EQUIPMENT ON AND OFF THE PROBLEM PERSISTED, AS THE DISPLAY SHOWED AIR IN THE SYSTEM AND IT WAS DELIVERING TOO MUCH SALINE SOLUTION DESPITE LOW FLOW AND PRESSURE; THEREFORE, THE SURGEON REQUESTED THAT A NEW DISPOSABLE DYONICS PUMP SET WAS OPENED, BUT THE PROBLEM PERSISTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483740 ↗
• MalfunctionFeb 17, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE DYONICS 25 CONTROL UNIT WAS PUMPING MORE THAN EXPECTED. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368432 ↗
• MalfunctionJan 27, 2026Increase in Pressure; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE PUMP OF THE DYONICS CONTROL UNIT WAS OVERPRESSURING THE JOINT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189549 ↗
• MalfunctionJan 21, 2026Increase in Pressure

  IT WAS REPORTED THAT ONE (1) DYONICS 25 CONTROL UNIT HAD A VARIATION IN PRESSURE, SUSPECTING AN ISSUE WITH THE PRESSURE SENSOR. THE PRESSURE WAS HIGHER THAN INTENDED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132540 ↗
• MalfunctionJan 7, 2026Excess Flow or Over-Infusion; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, A CONTROL UNIT, DYONICS 25 WAS NOT FUNCTION PROPERLY, IT WAS OVER RUNNING OR NOT WORKING AT ALL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988998 ↗
• MalfunctionJan 5, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, BEFORE A SHOULDER ARTHROSCOPY, IT WAS NOTICED THAT A CONTROL UNIT, DYONICS 25 WAS NOT OPERATING CORRECTLY. IT WAS USED AT A LOW FLOW RATE, HOWEVER, THE FLOW RATE REMAINED EXCESSIVELY HIGH. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956481 ↗
• MalfunctionDec 30, 2025Excess Flow or Over-Infusion; Overheating of Device; Pressure Problem; Excess Flow or Over-Infusion; Overheating of Device; Pressure Problem

  IT WAS REPORTED THAT DURING A HIP SCOPE PROCEDURE, THE DYONICS CONTROL UNIT WAS RUNNING HOT, ITS PRESSURE WAS SUPER HIGH AND EVEN WHEN IT WAS LOWERED, IT WAS SHOOTING WATER EVERYWHERE. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923170 ↗
• MalfunctionDec 18, 2025Increase in Pressure; Calibration Problem; Increase in Pressure; Calibration Problem

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE CONTROL UNIT DYONICS 25 PUMP WAS OUT OF CALIBRATION. EVEN AT THE LOW LEVEL, THE SALINE SOLUTION WAS COMING OUT WITH HIGH PRESSURE. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838676 ↗
• MalfunctionDec 16, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE PRESSURE OF A CONTROL UNIT, DYONICS 25 WAS AT 40 AND FLOW AT 8; HOWEVER, THE STAFF NOTICED A HIGH SALINE PRESSURE. IT WAS ADJUSTED AS THE SURGERY PROGRESSED, BUT THE FLOW REMAINED STRONG. THEY HAD TO REDUCE THE PUMP PRESSURE TO 30 MM TO FINISH THE PROCEDURE. THE PUMP WAS ADJUSTED TO MEDIUM FLOW. THE PATIENT'S SHOULDER WAS VERY SWOLLEN, AND THE DOCTOR CHOSE NOT TO DISCHARGE THE PATIENT THAT DAY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME FAULTY DEVICE.

  Patient problems: Swelling/ Edema

  MAUDE report 23821389 ↗
• MalfunctionNov 21, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED DURING A SHOULDER ARTHROSCOPY, THE DYONICS 25 CONTROL UNIT´S FLOW WAS FASTER THAN NORMAL, LEADING TO SWELLING OF THE SHOULDER, BACK AND CHEST. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 23616917 ↗
• MalfunctionNov 20, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING A SHOULDER ATC PROCEDURE, THE DYONICS 25 CONTROL UNIT APPEARED TO BE MALFUNCTIONING AS THE PRESSURE AND FLOW LIMITS SET LOW, THE AMOUNT OF SALINE SOLUTION DISPENSING FROM THE EQUIPMENT SEEMED GREATER THAN WHAT WAS DISPLAYED ON THE SCREEN. THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY, USING THE SAME PRODUCT. NO HARM OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607622 ↗
• MalfunctionNov 14, 2025Communication or Transmission Problem; Infusion or Flow Problem; Communication or Transmission Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A BIOABSORBABLE SHOULDER INSTABILITY AND ARTHRITIS PROCEDURE, THE EQUIPMENT OF ONE (1) DYONICS 25 CONTROL UNIT KEPT DISCONNECTING OR SHOWING AIR IN THE FLOW DISPLAY. THE CIRCULATING NURSE HAD TO MANUALLY REMOVE AND RECONNECT THE DISPOSABLE DEVICE SEVERAL TIMES. THE PATIENT'S ARM HAD MORE FLUID THAN USUAL. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 23556845 ↗
• MalfunctionNov 3, 2025Excess Flow or Over-Infusion; Pressure Problem; Excess Flow or Over-Infusion; Pressure Problem

  IT WAS REPORTED THAT BEFORE A PROCEDURE, ONE (1) DYONICS 25 CONTROL UNIT WAS RUNNING HIGH, IT WAS PUMPING MORE WATER THAN WHAT THE PRESSURE WAS SHOWING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450882 ↗
• MalfunctionOct 30, 2025Excess Flow or Over-Infusion; Calibration Problem; Pressure Problem; Excess Flow or Over-Infusion; Calibration Problem; Pressure Problem

  IT WAS REPORTED THAT, DURING A SURGERY, ONE (1) DYONICS 25 CONTROL UNIT WAS PUSHING MORE FLUID. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425608 ↗
• MalfunctionOct 15, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, ONE (1) DYONICS 25 CONTROL UNIT'S PRESSURE WAS NOT CALIBRATED CORRECTLY. THE PUMP PRESSURE WAS TOO HIGH DESPITE BEING SET ON A LOW SETTING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306093 ↗
• MalfunctionSep 29, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, A DISPOSABLE SET WAS PLACED ON THE DYONICS 25 CONTROL UNIT WITH SETTINGS AT 50° PRESSURE AND 1.0° FLOW. SEVEN MINUTES INTO THE SURGERY, THE SHOULDER BECAME EXTREMELY SWOLLEN. THE FLOW WAS MANAGED TO REDUCE TO 20° THEN 0.7°. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 23173571 ↗
• MalfunctionSep 22, 2025Increase in Pressure; Calibration Problem; Pressure Problem; Increase in Pressure; Calibration Problem; Pressure Problem

  IT WAS REPORTED THAT, DURING A BIOABSORBABLE SHOULDER CUFF PROCEDURE, IT WAS NOTICED THAT THE DYONICS CONTROL UNIT PUMP WAS OUT OF CALIBRATION AND WAS TOO POWERFUL. THEY SET THE FLOW RATE TO LOW, BUT WAS REMAINED VERY POWERFUL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23111426 ↗
• MalfunctionSep 9, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A TITANIUM CUFF ARTHROPUMP PROCEDURE, THE DYONICS 25 CONTROL UNIT WAS DEREGULATING, AS WHEN REMOVING THE DRAPES, IT WAS FOUND THAT THERE WAS TOO MUCH INFILTRATION IN THE PATIENT'S SHOULDER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005500 ↗
• MalfunctionSep 4, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, DURING SURGERY, THE DYONIC 25 CONTROL UNIT WAS DEREGULATED, INJECTING A LOT OF SERUM. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963570 ↗