Sonopet iQ 550025B114Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 07613327422498), received between Dec 19, 2019 and Apr 22, 2026 — classified as 3 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Fracture” (34 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fracture

  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 3 EVENTS FOR THE FAILURE: FRACTURE. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954022 ↗
• MalfunctionJan 23, 2026Fracture

  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: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163590 ↗
• 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 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163576 ↗
• 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 2 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE, 2 EVENTS HAD MINOR INJURY/ILLNESS/IMPAIRMENT.

  Patient problems: Burn(s)

  MAUDE report 23399812 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  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 3 EVENTS FOR THE FAILURE: FRACTURE. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369153 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647026 ↗
• MalfunctionMay 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORAL SURGERY, INCLUDING A MANDIBULAR AND MAXILLARY OSTEOTOMY, A SONOPET APEX KNIFE BROKE AND WAS LEFT IN THE PATIENT¿S FACE. PATIENT WILL REQUIRE AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE FOREIGN BODY. IT WAS ALSO REPORTED THAT THE ORAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AFTER A SURGICAL DELAY OF 20-30 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 21963550 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201033 ↗
• MalfunctionOct 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504501 ↗
• InjuryAug 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP BROKE, FRAGMENTS NEEDED TO BE REMOVED FROM THE PATIENT, ALL FRAGMENTS SUCCESSFULLY REMOVED. IT WAS ALSO REPORTED THAT DURING THE REMOVAL OF THE FRAGMENTS, THERE WAS A TWO-HOUR DELAY, AND THE PATIENT REQUIRED ADDITIONAL ANESTHESIA TO BE ADMINISTERED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT ANY MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19883715 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 3 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823002 ↗
• MalfunctionJun 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613333 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992796 ↗
• MalfunctionJul 26, 2023Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401586 ↗
• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398739 ↗
• MalfunctionJun 19, 2023Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PROCEDURE A FOREIGN MATERIAL WAS NOTICED BETWEEN THE TIP AND THE SLEEVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17150820 ↗
• MalfunctionApr 24, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SONOPET IQ TIP GOT HOT. THE PATIENT WAS BURNED ON THE FACE. THE BURN WAS LOCATED ON THE UPPER NOSE OF THE PATIENT. IT WAS APPROX 1CM IN SIZE. THE DOCTOR MENTIONED HE MAY TRY TO DO "PRP THEREAPY WITH MICRO NEEDLING". NO INFECTION WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR TIP 2 OF 2.

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

  MAUDE report 16794442 ↗
• MalfunctionApr 24, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SONOPET IQ TIP GOT HOT. THE PATIENT WAS BURNED ON THE FACE. THE BURN WAS LOCATED ON THE UPPER NOSE OF THE PATIENT. IT WAS APPROX 1CM IN SIZE. THE DOCTOR MENTIONED HE MAY TRY TO DO "PRP THEREAPY WITH MICRO NEEDLING". NO INFECTION WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR TIP 1 OF 2.

  Patient problems: Insufficient Information; Superficial (First Degree) Burn

  MAUDE report 16794441 ↗
• MalfunctionApr 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE KNIFE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16719989 ↗
• MalfunctionApr 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE AT THE TIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662829 ↗
• MalfunctionApr 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE AT THE TIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662824 ↗
• MalfunctionMar 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A JAWBONE OSTEOTOMY PROCEDURE, THE TIP BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538026 ↗
• MalfunctionFeb 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316113 ↗
• MalfunctionJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A OF A JAW DEFORMITY SURGICAL PROCEDURE, THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134517 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO SEPARATE TIPS BROKE DURING THE PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16021164 ↗