DYONICS 25 7211010FRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010643827), received between Nov 13, 2018 and Sep 30, 2025 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (9 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, DURING SET UP, THE DYONICS 25 CONTROL UNIT DID NOT ADJUST. IT WAS PUMPING AT A HIGH RATE AND DID NOT ADJUST ACCORDING TO PRESSURE SETTINGS. PRESSURE WAS HIGHER THAN INTENDED. THERE WAS A BACK-UP DEVICE AVAILABLE, AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23187541 ↗
• MalfunctionAug 4, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING SET UP, THE DYONICS 25 CONTROL UNIT WAS OVER PRESSURIZING. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700247 ↗
• InjuryJul 5, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A LABRAL REPAIR, THE DYONICS 25 CONTROL UNIT PUMP WAS CAUSING AN EXTREME EXTRAVASATION OF THE SHOULDER, THE PATIENT WAS HELD FOR AN EXTRA HOUR IN RECOVERY UNTIL THE FLUID DRAINED OUT ENOUGH AND THE SURGEON FELT COMFORTABLE OF IT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Extravasation

  MAUDE report 19683190 ↗
• MalfunctionApr 3, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, THE DYONICS 25 CONTROL UNIT WAS NOT PRESSURIZING CORRECTLY AND OVER PUMPS FLUID. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667737 ↗
• MalfunctionMay 21, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE CALIBRATION ON THE DYONICS CONTROL UNIT WAS NOT HOLDING AT THE PROPER SET PRESSURE LEVEL. THE PUMP WAS RUNNING TOO HIGH AND COULD NOT BE CORRECTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466562 ↗
• MalfunctionNov 30, 2021Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, THE DYONICS CONTROL UNIT WAS NOT HOLDING PRESSURE PROPERLY. PRESSURE WAS INCREASING SPORADICALLY. INCIDENT OCCURRED WHILE SETTING-UP FOR A KNEE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892865 ↗
• MalfunctionSep 10, 2021Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE DYONICS CONTROL UNIT INFUSED MORE LIQUID THAN USUAL TO THE SHOULDER'S PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456355 ↗
• MalfunctionMay 7, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DYONICS CONTROL UNIT HAD A LACK OF PRESSURE ISSUE DURING AN UNKNOWN PROCEDURE. IT IS UNKNOWN IF THERE WAS A BACKUP AVAILABLE OR A DELAY IN THE PROCEDURE. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795066 ↗
• MalfunctionMay 7, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DYONICS CONTROL UNIT HAD A LACK OF PRESSURE ISSUE DURING AN UNKNOWN PROCEDURE. IT IS UNKNOWN IF THERE WAS A BACKUP AVAILABLE OR A DELAY IN THE PROCEDURE. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794993 ↗
• MalfunctionMar 14, 2021Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION FOR AN UNKNOWN PROCEDURE, THE CONTROL UNIT WAS OVERPRESSURING. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS 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 11479042 ↗
• MalfunctionFeb 10, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE DYONICS 25 CONTROL UNIT WAS NOT REGULATING THE JOINT PRESSURE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11310932 ↗
• MalfunctionJan 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A SURGERY THE CONTROL UNIT PUMP WAS LOOSING THE SEAL CAUSING THAT THE CASSETTES TO COME AFAR. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11135263 ↗
• MalfunctionDec 8, 2020Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CONTROL UNIT WAS NOT HOLDING PRESSURE. NO CASE INVOLVED. 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 10973042 ↗
• MalfunctionOct 9, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE CONTROL UNIT KEEPS ALARMING. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; 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 Patient Involvement

  MAUDE report 10656925 ↗
• MalfunctionSep 12, 2020Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING SHOULDER SURGERY THE DYONICS 25 CONTROL UNIT WAS MOVING TO MUCH WATER, THE CALIBRATION WAS OFF. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP 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 10525941 ↗
• MalfunctionJul 12, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DYONICS PUMP WAS SPILLING WATER ON IT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES 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 10262244 ↗
• MalfunctionJun 13, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE DYONICS CONTROL UNIT DID NOT MAINTAIN THE PRESSURE. IT WENT THROUGH 4X THE AMOUNT OF FLUID THAT WAS NORMALLY USED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10151419 ↗
• MalfunctionMar 24, 2020Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE SURGEON FELT THAT THE DYONICS 25 CONTROL UNIT WAS PUTTING OUT PRESSURE HIGHER THAN IT SHOULD BE. THERE WAS A BACKUP DEVICE AVAILABLE; HOWEVER, THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY OR PATIENT INJURY WAS 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 9874046 ↗
• MalfunctionDec 18, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING ELBOW ARTHROSCOPY, DYONIC 25 WAS OVERHEATING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO 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 Known Impact Or Consequence To Patient

  MAUDE report 9490215 ↗
• MalfunctionNov 25, 2019Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY, THE FLOW WAS NOT WORKING PROPERLY. THE DEVICE WAS OVER-PRESSURIZED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO 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 Known Impact Or Consequence To Patient

  MAUDE report 9372065 ↗
• MalfunctionOct 7, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE CONTROL UNIT WAS NOT READING THE CASSETTE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9164892 ↗
• MalfunctionAug 25, 2019Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS NOT WORKING. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. A SIGNIFICANT DELAY MORE THAN 30 MINUTES WAS REPORTED WITHOUT PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8928790 ↗
• MalfunctionJul 28, 2019Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING SHOULDER PROCEDURE, THE MACHINE WAS NOT ALLOWING THE FLUID TO STOP. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8834747 ↗
• MalfunctionMay 17, 2019Pressure Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS NOT MAINTAINING THE PRESSURE; HOWEVER, THE JOINT WAS OVER PRESSURIZED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY NOR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8619488 ↗
• MalfunctionJan 8, 2019Excess Flow or Over-Infusion; Increase in Pressure

  IT WAS REPORTED THAT THE DEVICE HAD ALTERED LEVELS IN THE FLUID CAUSING OVERPRESSURE AND EXCESS OF FLOW. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8225852 ↗