DYONICS 25 72200211Recalls & reported problems
Smith & Nephew, Inc. · KIT DYONICS 25 UK · Class 2
All models of DYONICS 25 (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885554013061), received between Mar 17, 2021 and Mar 17, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Excess Flow or Over-Infusion1
Patient problems
- Extravasation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE "DYONICS 25 CONTROL SYSTEM" SWITCHED OFF AND TURNED BACK ON RESULTING IN SURGE OF FLUID INTO THE PATIENT'S JOINT CAUSING INTRAVASATION. ALTHOUGH THE SURGERY WAS NOT SIGNIFICANTLY DELAYED, IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Extravasation
MAUDE report 11507138 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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