Sonopet iQ 550025S307Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327422467), received between Feb 5, 2021 and Jan 23, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163985 ↗
• 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 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369151 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 2 EVENTS HAD INSUFFICIENT INFORMATION. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

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

  MAUDE report 22646730 ↗
• MalfunctionApr 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 21878623 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878620 ↗
• 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 19818526 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818326 ↗
• MalfunctionMay 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE TIP BROKE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE; NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313090 ↗
• MalfunctionApr 16, 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 19113502 ↗
• MalfunctionJan 4, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SCRUB TECHNICIAN RECEIVED A BURN ON THEIR HAND. THE BURN WAS BANDAGED AND THE SCRUB TECHNICIAN WAS TESTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 18443761 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THAT THE VERTEBRAL ARTERY WAS INJURED, THERE WAS NO SUDDEN DROP IN BLOOD PRESSURE AND THE ANESTHESIOLOGIST CONTROLLED AND STABILIZED THE BLOOD PRESSURE. CLIPPING AND SUTURING WERE PERFORMED ON THE PINHOLE PORTION OF THE VERTEBRAL ARTERY. AFTER THAT, POSTERIOR FIXATION WAS CONCLUDED AND THE STRATUM CORNEUM WAS CLOSED. POSTOPERATIVELY, THE PATIENT WAS MANAGED IN THE ICU. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Laceration(s)

  MAUDE report 18181586 ↗
• InjuryJul 18, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT RECEIVED A THIRD DEGREE BURN FROM THE SONOPET TIP. THE BURN WAS EXCISED AND TREATED WITH MONOCRYL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 17343249 ↗
• MalfunctionApr 25, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SONOPET IQ TIP SLEEVE WAS DAMAGED/MELTED. 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 16809044 ↗
• MalfunctionApr 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A DELAY OF 10 MINUTES TO THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16719986 ↗
• MalfunctionApr 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A 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 16672543 ↗
• MalfunctionJul 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY FOR TUMOUR RESECTION, THE SONOPET IQ TIP BROKE. IT WAS ALSO REPORTED THAT THERE WAS A SMALL DELAY WHILE THE PART WAS RETRIEVED AND THE WERE NO ADVERSE CONSEQUENCES 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 15099499 ↗
• MalfunctionMay 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES 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 14409118 ↗
• MalfunctionFeb 5, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE SCRUB TECH HELD THE TIP OF THE DEVICE WHILE IT WAS ACTIVATED WHICH RESULTED IN THE TIP BURNING THROUGH THE SCRUB TECHS GLOVE AND BURN TO THE TIP OF A FINGER. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED.

  Patient problems: Burn(s)

  MAUDE report 11285584 ↗