Maestro 5400210060Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 04546540469229), received between Jul 24, 2018 and Apr 22, 2026 — classified as 2 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (41 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 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Overheating of Device

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 27 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 26 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954403 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) ¿ (B)(6) 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953973 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FLUID/BLOOD LEAK. - 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163421 ↗
• MalfunctionJan 23, 2026Overheating of Device

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31, 2025. THIS REPORT SUMMARIZES 24 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 19 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 5 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163079 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399846 ↗
• MalfunctionOct 23, 2025Overheating of Device; Overheating of Device

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 23 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE: 4 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT, 18 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT, 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368871 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT. 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647024 ↗
• MalfunctionJul 29, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 13 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 7 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 5 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646534 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876264 ↗
• MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876052 ↗
• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207501 ↗
• MalfunctionJan 21, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 8 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201162 ↗
• MalfunctionOct 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501411 ↗
• MalfunctionOct 21, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 32 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 23 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 9 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496822 ↗
• MalfunctionJul 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823205 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 13 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 11 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823135 ↗
• MalfunctionJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822905 ↗
• MalfunctionApr 16, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 29 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 16 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 11 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 2 EVENTS HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113389 ↗
• InjuryFeb 19, 2024Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE DEVICE STOPPED WORKING DURING A PROCEDURE. A SURGICAL DELAY OF AT LEAST TWO HOURS WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING MANUAL INSTRUMENTATION WITH NO MEDICAL INTERVENTION REPORTED. THIS REPORT IS BEING SUBMITTED DUE TO THE PROLONGATION OF THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735805 ↗
• InjuryFeb 19, 2024Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE DEVICE STOPPED WORKING DURING A PROCEDURE. A SURGICAL DELAY OF AT LEAST TWO HOURS WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION REPORTED. THIS REPORT IS BEING SUBMITTED DUE TO THE PROLONGATION OF THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735803 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557284 ↗
• MalfunctionJan 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556872 ↗
• MalfunctionOct 23, 2023Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 23 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 22 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993051 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992982 ↗
• MalfunctionOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992979 ↗