NA 7211010SRRecalls & reported problems
Smith & Nephew, Inc. · DYONICS 25 FLUID MANAGEMENT CONTROL UNIT SERVICE REPLACEMENT · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556586372), received between Oct 3, 2017 and Mar 7, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Inoperable” (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 16, 2026.
Most reported problems
Device problems
- Device Inoperable1
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2018Device Inoperable
IT WAS REPORTED THAT THE TRANSDUCER IS NOT WORKING SINCE ITS OVERFLOWING. NO PATIENT INJURY OR SIGNIFICANT TIME DELAY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7320191 ↗MalfunctionOct 3, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE DYONICS 25 OVER PRESSURIZED THE SHOULDER, THE DEVICE WAS NOT READING THE PRESSURE AND FLOW CORRECTLY. THERE WAS NO SIGNIFICANT SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6912792 ↗
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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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