NA 7211005Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010543578), received between Dec 27, 2017 and Aug 20, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2024Device Alarm System; Increase in Pressure; Device Alarm System; Increase in Pressure

  IT WAS REPORTED THAT DURING SET UP AN ARTHROSCOPY, AFTER SETTING UP AND PRESSING START ON THE DYONICS INFLOW/OUTFLOW TUBE SET THE PRESSURE WENT TO 999 AND AN STANDARD ERROR ALARM SOUNDED. THE PUMP WAS CHANGED AND STILL THE SAME. THERE WAS A BACK-UP DEVICE AVAILABLE, AND A NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002410 ↗
• MalfunctionDec 15, 2023Excess Flow or Over-Infusion; Pressure Problem; Excess Flow or Over-Infusion; Pressure Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DYONICS 25 TUBE SET WAS NOT PRESSURIZING CORRECTLY AND FLUID WAS OVER PUMPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 5 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336498 ↗
• MalfunctionDec 9, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING SET UP FOR AN ARTHROSCOPY, WHEN THE OUTER PACKAGE WAS OPENED, THE INNER PACKAGE OF THE DYONICS 25 INFLOW/OUTFLOW TUBE SET HAD A SMALL HOLE. SURGERY WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949176 ↗
• MalfunctionApr 12, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE PRESSURE OF THE DYONICS 25 INFLOW/OUTFLOW TUBE WAS OVER 400. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084822 ↗
• MalfunctionApr 12, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE PRESSURE OF THE DYONICS 25 INFLOW/OUTFLOW TUBE WAS OVER 400. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084435 ↗
• MalfunctionJul 31, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, DURING SURGERY, THE "DYONICS 25 INFLOW//OUTFLOW TUBE SET" WAS OVERRUNNING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257164 ↗
• MalfunctionApr 29, 2021Leak/Splash; Component Missing; Leak/Splash; Component Missing

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR AN ARTHROSCOPY, WATER LEAKING WAS NOTICED FROM THE CASSETTE OF THE FLUID MANAGEMENT SYSTEM. UPON FURTHER INSPECTION A MISSING MEMBRANE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO INJURIES 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 11750585 ↗
• MalfunctionMar 15, 2021Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE DYONICS 25 INFLOW/OUTFLOW TUBE SET PACKAGE WAS OPENED, THE SURGEON NOTICED THAT THE CELLOPHANE TAPE WAS ALREADY ATTACHED TO INSIDE THE STERILIZATION TRAY AND A FOREIGN MATERIAL SIMILAR TO DUST WAS FOUND TO BE SEALED IN A PACKAGE, SO THE STAFF TAPED THE FOREIGN MATERIAL TO THE AREA WHERE IT WAS FOUND. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE AND THERE WAS NO DELAY NOR OTHER COMPLICATION 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 11490015 ↗
• MalfunctionFeb 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT, DURING A MENISCUS PROCEDURE, THE CASSETTE OF THE DYONICS 25 WAS LEAKING FLUID. 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 11298402 ↗
• MalfunctionSep 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A FLUID LEAKAGE FROM THE CASSETTE. 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 10566365 ↗
• MalfunctionFeb 22, 2019Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN INSERTING THE SINGLE-USE KIT OF THE DYONICS PUMP 25 INTO THE CONTROL UNIT, THE BOX WAS NOT RECOGNIZED BY THE CONTROL UNIT, SO IT WAS NOT USABLE (THEY THEN USED A KIT WITH DIFFERENT LOT). NO PATIENT INJURY REPORTED. BACK-UP DEVICE WAS AVAILABLE. DELAY GREATER THAN 30 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8362462 ↗
• MalfunctionJun 24, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT T1 AND T2 DEPLOY TOGETHER DURING PROCEDURE. NO PATIENT INJURY WAS REPORTED. BACK-UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7632631 ↗
• MalfunctionDec 27, 2017Loss of Power; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE FLUID LEAKED FROM THE CASSETTE AND THE CONTROL UNIT POWERED OFF AND AFTER DISPLAYED AN ERROR MESSAGE. PROCEDURE HAD TO BE COMPLETED BY GRAVITY INFLOW WITHOUT USING THE CONTROL UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT INJURIES OR COMPLICATIONS. AFTER THE EVENT, IT WAS CONFIRMED THAT THE TRANSDUCER MEMBRANES WAS MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7148424 ↗