NA 7211010S3ERecalls & reported problems
Smith & Nephew, Inc. · DYONICS 25 FLUID MANAGEMENT CONTROL UNIT SERVICE REPLACEMENT THIRD EDITION CONTROL UNIT ONLY · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885554030822), received between Feb 19, 2018 and Aug 20, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (2 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
Device problems
- Pressure Problem2
- Device Displays Incorrect Message1
- Overheating of Device1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY FOR ROTATOR CUFF REPAIR, THE CIRCULATOR SMELLED SMOKE. THE DYONICS 25 FLUID MANAGEMENT SYSTEM WAS SHOWING GLOWING ORANGE FLICKER ON LOWER LEFT FACING THE MACHINE SO IT WAS UNPLUGGED AND REMOVED FROM THE ROOM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12347253 ↗MalfunctionJun 17, 2018Pressure Problem
IT WAS REPORTED THAT THE DEVICE WAS OVERPRESSURIZING; THEREFORE, IT HAD AN INCONSISTENT PRESSURE. THE CASE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7608481 ↗MalfunctionFeb 20, 2018Pressure Problem
IT WAS REPORTED THAT DEVICE WAS NOT MAINTAINING PRESSURE, THERE WAS CONTINUOUS BLEEDING CAUSING LOSS OF VISUALIZATION DURING PROCEDURE. SPORADIC FLUSHING OF THE JOINT WAS NEEDED TO COMPLETE THE CASE WITH THE SAME DEVICE. DESPITE THE MALFUNCTION, NO PROCEDURE DELAY OR PATIENT INJURIES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7283656 ↗MalfunctionFeb 19, 2018Device Displays Incorrect Message
IT WAS REPORTED BY CUSTOMER THAT DEVICE PRESENTED AND INCORRECT TUBE SET ERROR. NO BACK-UP WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7281326 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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