Foot Control H3000-01Recalls & reported problems
Smith & Nephew, Inc. · FOOT CONTROL ATLAS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00817470002072), received between Oct 3, 2024 and Mar 23, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking3
- Self-Activation or Keying2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Self-Activation or Keying
IT WAS REPORTED THAT A FOOT CONTROL ASSEMBLY WAS SENDING THE CUTTING SIGNAL TO THE HANDPIECE EVEN WHEN IT WAS NOT PRESSED. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24669675 ↗MalfunctionOct 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT BEFORE A KNEE ARTHROSCOPY, THE BLUE COAGULATION PEDAL OF THE FOOT CONTROL ASSEMBLY REMAINED PRESSED WHEN ACTIVATED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437811 ↗MalfunctionOct 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE FOOT CONTROL ASSEMBLY WAS STUCK AS WHILE PRESSING IT AND ACTIVATING IT, THE PEDAL WAS NOT GETTING RELEASED CAUSING THE HANDPIECE TO GENERATE PLASMA CONTINUOUSLY WITHOUT ACTIVATION. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23294423 ↗MalfunctionOct 16, 2024Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED THAT, DURING SET UP, THE FOOT CONTROL HAD A DAMAGE ON THE CABLE. THE FOOT CONTROL WENT INTO CUT MODE WITHOUT THE PEDALS BEING PRESSED. 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 20464259 ↗MalfunctionOct 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING ROUTINE INSPECTION, THE FOOT PEDAL WAS STRUCK, WHILE PRESSING AND ACTIVATING THE PEDAL IT WAS NOT GETTING RELEASED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20358844 ↗
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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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