Sonopet iQ 5500255000Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 07613327298611), received between Jan 29, 2020 and Jul 22, 2026 — classified as 6 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (24 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Inability to Irrigate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907784 ↗
• MalfunctionApr 22, 2026Inability to Irrigate

  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 2 EVENTS FOR THE FAILURE: INABILITY TO IRRIGATE. 1 EVENT 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 24953806 ↗
• MalfunctionJan 29, 2026Inability to Irrigate

  THE MANUFACTURER SALES REP REPORTED THAT THE DEVICE DID NOT IRRIGATE. NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 24208367 ↗
• MalfunctionJan 23, 2026Inability to Irrigate

  NO CHANGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163719 ↗
• 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 4 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163093 ↗
• MalfunctionOct 28, 2025Inability to Irrigate; Inability to Irrigate

  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 6 EVENTS FOR THE FAILURE: INABILITY TO IRRIGATE. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 5 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399829 ↗
• MalfunctionOct 28, 2025Inability to Irrigate; Overheating of Device; Inability to Irrigate; 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 2 EVENTS FOR THE FAILURES: INABILITY TO IRRIGATE; OVERHEATING OF DEVICE, 2 EVENTS HAD MINOR INJURY/ILLNESS/IMPAIRMENT.

  Patient problems: Burn(s)

  MAUDE report 23399801 ↗
• MalfunctionOct 28, 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 12 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 1 EVENT HAD INSUFFICIENT INFORMATION. 5 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. 2 EVENTS HAD MINOR INJURY/ILLNESS/IMPAIRMENT. 4 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Burn(s); Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399783 ↗
• MalfunctionJul 29, 2025Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 6 EVENTS FOR THE FAILURE: INABILITY TO IRRIGATE. - 4 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD INSUFFICIENT INFORMATION. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 22648126 ↗
• MalfunctionJul 29, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT. 3 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646728 ↗
• InjuryApr 8, 2025No Apparent Adverse Event; No Apparent Adverse Event

  AFTER ATTEMPTING TO GATHER MORE INFORMATION ABUT THE FOLLOW REPORTED, WE WERE UNABLE TO DETERMINE IF ANY OF THIS WAS COMPLETED. PER SALES REPRESENTATIVE, THERE WAS NO ALLEGED DEVICE ISSUE DURING PROCEDURE.

  Patient problems: Numbness

  MAUDE report 21800040 ↗
• MalfunctionMar 3, 2025Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE PROCEDURE WAS COMPLETED. THERE WAS NO INDICATION THAT THE PATIENT REQUIRED FURTHER MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. BASED ON THE INVESTIGATION RESULTS, THIS EVENT IS NOT-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505696 ↗
• MalfunctionJan 22, 2025Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208421 ↗
• MalfunctionJan 21, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200735 ↗
• MalfunctionOct 22, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 3 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502092 ↗
• MalfunctionOct 21, 2024Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 3 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20498146 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823147 ↗
• MalfunctionJul 24, 2024Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. - 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 19823140 ↗
• MalfunctionApr 16, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 9 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 19113507 ↗
• MalfunctionApr 16, 2024Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 3 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113506 ↗
• InjuryMar 7, 2024Accessory Incompatible; Adverse Event Without Identified Device or Use Problem; Accessory Incompatible; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE DEVICE STOPPED WORKING (DISPLAYED AN ERROR CODE) 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 18856133 ↗
• MalfunctionJan 22, 2024Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. - 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557623 ↗
• MalfunctionOct 23, 2023Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993046 ↗
• MalfunctionJul 27, 2023Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404018 ↗
• MalfunctionJul 26, 2023Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397025 ↗