NA 5407-120-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 07613327096675), received between Jul 24, 2018 and Apr 22, 2026 — classified as 88 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (42 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 88 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 39 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 38 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 24954381 ↗
• MalfunctionJan 23, 2026Flaked

  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 14 EVENTS FOR THE FAILURE: FLAKED. - 14 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163072 ↗
• 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 25 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 18 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 4 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163069 ↗
• 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 11 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 8 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368905 ↗
• MalfunctionOct 23, 2025Flaked; Flaked

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368899 ↗
• MalfunctionJul 24, 2025Flaked; Flaked

  THIS REPORT SUMMARIZES 14 EVENTS FOR THE FAILURE: FLAKED. - 14 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587808 ↗
• MalfunctionJul 24, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 27 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 8 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 17 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586850 ↗
• MalfunctionApr 21, 2025Flaked; Flaked

  THIS REPORT SUMMARIZES 24 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 24 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 21876835 ↗
• MalfunctionApr 21, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 19 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 17 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT HAD PATIENT INVOLVEMENT - NO PATIENT IMPACT. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.

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

  MAUDE report 21876694 ↗
• MalfunctionApr 21, 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 21876268 ↗
• MalfunctionJan 21, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 25 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 22 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201168 ↗
• MalfunctionJan 21, 2025Flaked; Flaked

  THIS REPORT SUMMARIZES 20 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 20 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 21200992 ↗
• MalfunctionOct 21, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 32 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 32 EVENTS HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500368 ↗
• MalfunctionOct 21, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 43 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 39 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496256 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 47 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 43 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823086 ↗
• MalfunctionJul 24, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 26 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 26 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822790 ↗
• MalfunctionApr 16, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 31 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 31 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113401 ↗
• MalfunctionApr 16, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 31 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 31 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113400 ↗
• MalfunctionJan 22, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 32 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 29 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557675 ↗
• MalfunctionJan 22, 2024Detachment 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 PATIENT INVOLVEMENT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556883 ↗
• MalfunctionJan 16, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 30 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 30 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518016 ↗
• MalfunctionOct 23, 2023Detachment 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 NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993222 ↗
• MalfunctionOct 23, 2023Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 51 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 45 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 6 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993098 ↗
• MalfunctionOct 23, 2023Flaked; Flaked

  THIS REPORT SUMMARIZES 45 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 45 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992902 ↗
• MalfunctionJul 26, 2023Detachment 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 NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401899 ↗