Sonopet iQ 550025B312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327422412), received between Mar 4, 2021 and Aug 9, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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.

• InjuryAug 9, 2024Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED POSTOPERATIVE, THE PATIENT EXPERIENCED RIGHT L5 AREA SENSORY LOSS, WEAKNESS OF FOOT TO TOE MUSCLES (FOOT MEDIAL ROTATION, DROP TOE), DUE TO DAMAGE CAUSED DURING USE OF THE SONOPET IQ TIP. IT WAS FURTHER REPORTED THAT THE PATIENT IS DOING WELL, AND SENSORY LOSS HAS RETURNED. IT WAS ALSO REPORTED THAT THE ORIGINAL PROCEDURE FORL4-5 LAMINECTOMY, RIGHT HERNIOTOMY, WAS COMPLETED SUCCESSFULLY, WITH NO MEDICAL INTERVENTION OR DELAYS.

  Patient problems: Muscle Weakness/Atrophy; Nerve Damage

  MAUDE report 19950804 ↗
• InjuryAug 9, 2024Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED POSTOPERATIVE, THE PATIENT EXPERIENCED SENSORY LOSS IN RIGHT L5 AREA, MILD MUSCLE WEAKNESS, DUE TO DAMAGE CAUSED DURING USE OF THE SONOPET IQ TIP. IT WAS FURTHER REPORTED THAT THE PATIENT WILL CONTINUE TO BE MONITORED. IT WAS ALSO REPORTED THAT THE ORIGINAL PROCEDURE FOR L3/4-L4 LAMINECTOMY, LEFT MASSIVE HERNIOTOMY, WAS COMPLETED SUCCESSFULLY, WITH NO MEDICAL INTERVENTION OR DELAYS.

  Patient problems: Ambulation or Postural Difficulties; Muscle Weakness/Atrophy; Nerve Damage

  MAUDE report 19950664 ↗
• MalfunctionApr 16, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - (B)(4) EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113504 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THERE WAS NO MALFUNCTION REPORTED WITH THE PRODUCT USED. IT WAS FURTHER REPORTED THAT THE PATIENTS REQUIRED MEDICAL INTERVENTION TO TREAT A CUT CAUSED BY UNINTENDED ACTIVATION OF THE PRODUCT. IT WAS ALSO REPORTED THAT A DELAY OF 30 MINUTES OCCURRED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Abrasion

  MAUDE report 11413222 ↗