INTELLIO SHIFT 72290011Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556805015), received between May 31, 2025 and Feb 5, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Degraded; Electrical /Electronic Property Problem; Self-Activation or Keying; Intermittent Energy Output

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN ONE (1) WIRED FOOT PEDAL WAS PRESSED, IT MAY WORK, BUT DOES NOT STOP WHEN UNPRESSED, OR IT MAY NOT WORK WHEN PRESSED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270316 ↗
• MalfunctionFeb 2, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE YELLOW ABLATE PEDAL OF AN INTELLIO SHIFT FOOT PEDAL BECAME STUCK IN THE DOWN OR ON POSITION, THE FLOW 50 WAND STAYED IN THE "ON" MOOD AND THE ONLY WAY TO TURN IT OFF WAS BY UNPLUGGING THE FOOTPEDAL FROM THE INTELLIO SHIFT CONTROLLER. THE SURGEON WAS ABLE TO KEEP THE DEVICE AWAY FROM ANY TISSUE SO THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241102 ↗
• MalfunctionJan 12, 2026Break; Self-Activation or Keying; Material Deformation

  IT WAS REPORTED THAT THE INTELLIO SHIFT WIRED FOOT PEDAL MIDDLE PEDAL WAS BROKEN. AS THIS WAS NOTICED DURING INSTALLATION, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037432 ↗
• MalfunctionMay 31, 2025Overheating of Device; Self-Activation or Keying; Physical Resistance/Sticking; Overheating of Device; Self-Activation or Keying; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE INTELLIO FOOT PEDAL BECAME STUCK, IT STARTED RUNNING THE WAND ON ITS OWN AND BURNT THROUGH ONE DRAPE BEFORE BEING UNPLUGGED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF 5 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120530 ↗