Sonopet iQ 5500573000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327298635), received between Jan 17, 2020 and Oct 23, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 17992794 ↗
• MalfunctionJul 26, 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 17397016 ↗
• MalfunctionJul 29, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A SURGERY A NURSE NOTED THE TUBING WAS KINKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10337832 ↗
• MalfunctionJan 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PROCEDURE FOR AN ACOUSTIC NEUROMA THE IRRIGATION CASSETTE WAS LEAKING. THE ACCOUNT REPORTED DETECTING AN ELECTRICAL BURNING SMELL AND THEN THE CONSOLE STOPPED WORKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A BRIEF DELAY TO RETRIEVE BACK-UP EQUIPMENT. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9603210 ↗