Sonopet iQ 550025B303Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327422450), received between Nov 18, 2020 and Jan 23, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• 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 (B)(6) 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 24163092 ↗
• MalfunctionNov 23, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, IT WAS NOTED THAT THE TIP SLEEVE HAD MELTED. IT WAS FURTHER REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO DELAY, ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15854614 ↗
• InjuryFeb 17, 2021Excessive Heating

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF A TRANS-MAXILLARY APPROACH TO CRANIAL BASE, THE TIP OF THE DEVICE OVERHEATED MELTING THE PLASTIC SLEEVE. IT WAS ALSO REPORTED THAT THE OVERHEATING CAUSED BURNS TO THE PATIENT AND SURGICAL SITE REQUIRING AN ADDITIONAL PROCEDURE TO REPAIR. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Burn(s)

  MAUDE report 11340203 ↗
• MalfunctionNov 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE 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 10862815 ↗