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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 2 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

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