Sonopet iQ 5500050000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327364675), received between Mar 23, 2021 and Apr 22, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (19 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 1 EVENT FOR THE FAILURE: INABILITY TO IRRIGATE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954419 ↗
• MalfunctionJan 23, 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 OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: INABILITY TO IRRIGATE. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163400 ↗
• MalfunctionOct 23, 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 1 EVENT FOR THE FAILURE: INABILITY TO IRRIGATE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369152 ↗
• MalfunctionSep 8, 2025Melted

  BURN NOTED BY SURGEON TO PATIENT'S LEFT NOSTRIL. SONOPET HANDPIECE REMOVED FROM STERILE FIELD. PLASTIC SLEEVE WAS NOTED TO BE MELTED.

  Patient problems: Burn(s)

  MAUDE report 22991096 ↗
• MalfunctionJul 24, 2025Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: INABILITY TO IRRIGATE. 2 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 22586847 ↗
• MalfunctionApr 21, 2025Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 5 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. 4 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876610 ↗
• MalfunctionJan 21, 2025Inability 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 THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PATIENT INVOLVEMENT, NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201190 ↗
• MalfunctionOct 21, 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. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501011 ↗
• MalfunctionJul 24, 2024Inability 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 19823122 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Suction Failure; Adverse Event Without Identified Device or Use Problem; Suction Failure

  THE USER FROM USER FACILITY REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD LACK OF ASPIRATION THAT RESULTED IN RESCHEDULE OF THE PROCEDURE. THIS REPORT IS BEING SUBMITTED FOR THE RESCHEDULED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19487945 ↗
• MalfunctionJan 22, 2024Inability 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 PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556800 ↗
• MalfunctionOct 23, 2023Inability to Irrigate; Inability to Irrigate

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992976 ↗
• MalfunctionJul 26, 2023Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. - 2 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 17401350 ↗
• MalfunctionApr 24, 2023Inability 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 16801679 ↗
• MalfunctionJan 29, 2023Inability 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 16261795 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE AT THE USER FACILITY, THE TIP OF THE DEVICE DAMAGED THE PATIENT¿S DURA, UNINTENTIONALLY CREATING AN OPENING IN THE DURA THAT WAS REQUIRED TO BE SUTURED. THERE WAS NO CLINICALLY-INSIGNIFICANT DELAY WITH THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Rupture

  MAUDE report 16096603 ↗
• MalfunctionOct 24, 2022Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. - 1 EVENT 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 15663613 ↗
• MalfunctionJul 26, 2022Inability 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 PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102439 ↗
• MalfunctionOct 22, 2021Inability 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 12680377 ↗
• MalfunctionJul 21, 2021Inability 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 PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204186 ↗
• MalfunctionApr 26, 2021Inability 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 11728359 ↗
• MalfunctionMar 23, 2021Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY THE DEVICE EXPERIENCED INTERMITTENT IRRIGATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555648 ↗