NA 5407-FA1-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 07613327096385), received between Jul 24, 2018 and Apr 22, 2026 — classified as 1 injury, 81 malfunctions.

The most frequently reported specific device problem is “Flaked” (33 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 82 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 4 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 2 EVENTS 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 24953802 ↗
• MalfunctionJan 23, 2026Flaked

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164007 ↗
• 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 (B)(6) 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163969 ↗
• 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 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369135 ↗
• MalfunctionOct 23, 2025Flaked; Flaked

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369124 ↗
• MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment 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 JULY 1 ¿ SEPTEMBER 30 2025. 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 23369121 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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 22648129 ↗
• MalfunctionJul 24, 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 APRIL 1 ¿ JUNE 30 2025. THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 4 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587168 ↗
• MalfunctionJul 24, 2025Flaked; Flaked

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30, 2025. THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: FLAKED. - 4 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586843 ↗
• MalfunctionApr 21, 2025Flaked; Flaked

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 5 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 21876816 ↗
• MalfunctionApr 21, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 6 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 21876679 ↗
• MalfunctionJan 22, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 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 21207518 ↗
• MalfunctionJan 21, 2025Flaked; Flaked

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201009 ↗
• MalfunctionOct 22, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 4 EVENTS HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501547 ↗
• MalfunctionOct 21, 2024Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20499071 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823103 ↗
• MalfunctionJul 24, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 11 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 11 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822804 ↗
• MalfunctionApr 16, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 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 19113511 ↗
• MalfunctionApr 16, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 12 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 12 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113510 ↗
• MalfunctionJan 22, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 7 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 18557716 ↗
• MalfunctionJan 16, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517670 ↗
• MalfunctionOct 23, 2023Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993101 ↗
• MalfunctionOct 23, 2023Flaked; Flaked

  THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 7 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992907 ↗
• MalfunctionJul 26, 2023Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 5 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401589 ↗
• MalfunctionJul 26, 2023Flaked; Flaked

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397686 ↗