CORE, Maestro 5400218000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613154410224), received between Apr 24, 2019 and Jan 29, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A STICKY SAFETY DEVICE THAT COULD LEAD TO UNINTENDED POWER-UP. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261800 ↗
• MalfunctionJan 19, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A STICKY SAFETY DEVICE THAT COULD LEAD TO UNINTENDED POWER-UP. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289976 ↗
• MalfunctionOct 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A STICKY SAFETY DEVICE THAT COULD LEAD TO UNINTENDED POWER-UP. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12679884 ↗
• MalfunctionApr 26, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS STICKING, WHICH COULD LEAD TO UNINTENDED POWER-UP. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728576 ↗
• MalfunctionJan 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A STICKY PEDAL THAT COULD LEAD TO UNINTENDED POWER-UP. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11215164 ↗
• MalfunctionJan 28, 2020Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9636716 ↗
• MalfunctionOct 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A STICKY SAFETY DEVICE THAT COULD LEAD TO UNINTENDED POWER-UP. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9245351 ↗
• MalfunctionApr 24, 2019Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8546023 ↗