Sonopet iQ 550025B315Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327422382), received between Feb 10, 2021 and Oct 29, 2024 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2024Overheating of Device; Overheating of Device

  IT WAS ORIGINALLY REPORTED THAT DURING A PROCEDURE, A PATIENT WAS CUT FROM A DEVICE THAT WAS LEFT ON THE DRAPE, AND INACTIVE. UPON FURTHER INVESTIGATION, IT WAS REPORTED THAT THE PATIENT WAS NOT CUT, BUT DID RECEIVE A SMALL BURN TO THEIR PALM, THIS WAS TREATED WITH AN OINTMENT. IT WAS ALSO REPORTED THAT THE THERE WAS AN UNKNOWN DELAY, AND THE PROCEDURE WAS COMPETED SUCCESSFULLY.

  Patient problems: Burn(s)

  MAUDE report 20560244 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818525 ↗
• MalfunctionApr 26, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENTS SKIN GOT BURNED. IT WAS FURTHER REPORTED, THAT THERE WAS NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Burn(s)

  MAUDE report 19191497 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGERY, THE SURGEON MISTAKENLY CONTACTED THE SONOPET TIP ON THE VESSEL AND THE BLOOD VESSEL WAS DAMAGED. AN ANGIORRHAPHY WAS PERFORMED TO REPAIR THE VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A 60 MINUTE DELAY. IT WAS FURTHER REPORTED THAT 1 WEEK LATER, A SUBARACHNOID HEMORRHAGE HAPPENED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17834861 ↗
• MalfunctionMar 28, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A JAWBONE OSTEOTOMY, A PATIENT HAD A BURN INJURY ON THE MOUTH CORNER. AN ANTIBIOTIC OINTMENT WAS PRESCRIBED TO TREAT THE BURN BY KEEPING THE AREA MOIST. THE BURN WILL NOT NEED ADDITIONAL TREATMENT AND NO INFECTION WAS OBSERVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 16625938 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE PATIENT EXPERIENCED A DURAL INJURY. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Rupture

  MAUDE report 16130744 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE TIP OF THE DEVICE DAMAGED THE PATIENTS DURA. IT WAS ALSO REPORTED THAT THERE WAS AN UNINTENTIONAL DURAL OPENING AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THE PATIENTS DURA REQUIRED TO BE SUTURED. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Rupture

  MAUDE report 16070980 ↗
• InjuryNov 4, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A RHINOPLASTY, THE SURGEON REQUESTED THE SUCTION TURNED DOWN AND THE TECH ACCIDENTLY CLAMPED THE SUCTION IRRIGATION. THE PATIENT WAS BURNED. THE PATIENT WAS IMMEDIATELY TREATED WITH COLD SALINE FLUSHES AND SOAKED GAUZE, FOLLOWED BY ANTIBIOTIC COVERAGE WITH ADAPTIC DRESSING. CONTINUAL OINTMENT COVERAGE, ADAPTIC DRESSING AND BANDAID. IT WAS FURTHER REPORTED THAT THERE WAS A SLIGHT SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15736434 ↗
• MalfunctionFeb 10, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL DECOMPRESSION, PEDIATRIC SURGICAL PROCEDURE, THE HANDPIECE BURNED THE RIGHT HAND OF THE SURGEON AND ALSO THE PATIENTS NECK. IT WAS ALSO REPORTED THAT A NEW TIP WAS FITTED AND THE HANDPIECE CONTINUED TO OVERHEAT. THIS RECORD ADDRESSES ONE OF THE TIPS THAT CONTRIBUTED TO THE OVERHEATING EVENT.IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A 10 MINUTE DELAY OCCURRED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309675 ↗
• MalfunctionFeb 10, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL DECOMPRESSION, PEDIATRIC SURGICAL PROCEDURE, THE HANDPIECE BURNED THE RIGHT HAND OF THE SURGEON AND ALSO THE PATIENTS NECK. IT WAS ALSO REPORTED THAT A NEW TIP WAS FITTED AND THE HANDPIECE CONTINUED TO OVERHEAT. THIS RECORD ADDRESSES ONE OF THE TIPS THAT CONTRIBUTED TO THE OVERHEATING EVENT. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A 10 MINUTE DELAY OCCURRED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309633 ↗