Sonopet iQ 550025B302Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07613327422528), received between Aug 4, 2020 and Apr 22, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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 23 most recent of 23 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 (B)(6) 2026. 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 24953793 ↗
• MalfunctionOct 28, 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 2 EVENTS FOR THE FAILURE: FRACTURE, 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399823 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  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 22647449 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19823126 ↗
• MalfunctionJan 22, 2024Fracture; Overheating of Device; Fracture; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556297 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 18556049 ↗
• InjuryNov 28, 2023Fracture; Fracture

  PER MEDWATCH REPORT MW5147031: IT WAS REPORTED THAT DURING A PROCEDURE THE SONOPET TIP BROKE OFF AND FELL INTO THE RECESS OF THE SPHENOID SINUS AND WAS UNABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS SEEN THE FOLLOWING WEEK IN THE ENT OFFICE AND WHEN PACKING WAS REMOVED FROM THE SITE, THE TIP WAS EASILY SUCTIONED OUT ONCE SHE WAS IN AN UPRIGHT POSITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18220150 ↗
• MalfunctionJul 26, 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 17397019 ↗
• MalfunctionApr 25, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808824 ↗
• MalfunctionMar 21, 2023Fracture; Overheating of Device; Fracture; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP BROKE. THE TIP HAD BEEN USED FOR ABOUT 5 MINUTES STRAIGHT BEFORE INCIDENT HAPPENED. THE POWER WAS TURNED ALL THE WAY UP, THE IRRIGATION WAS TURNED DOWN. THE DEVICE HAD A HEATING ISSUE, WHICH CAUSED A BREAK. 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 16584342 ↗
• MalfunctionJan 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A LUMBAR SPINAL STENOSIS SURGICAL PROCEDURE, THE TIP OF TWO SEPARATE DEVICES 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 TIPS WHICH WAS REPORTED TO HAVE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16138020 ↗
• MalfunctionJan 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A LUMBAR SPINAL STENOSIS SURGICAL PROCEDURE, THE TIP OF TWO SEPARATE DEVICES 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 TIPS WHICH WAS REPORTED TO HAVE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137934 ↗
• InjuryJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE BROKE IN THE PATIENT. IT WAS ALSO REPORTED THAT A FRAGMENT OF THE TIP OF THE DEVICE REMAINED IN THE PATIENT WHICH REQUIRES AN ADDITIONAL SURGERY TO REMOVE THE FRAGMENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134704 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE BROKE IN THE PATIENT AND WAS RETRIEVED SUCCESSFULLY. 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 15392693 ↗
• MalfunctionJul 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT 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 15021491 ↗
• MalfunctionFeb 3, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING DEVICE EVALUATION AT THE MANUFACTURER, THERE WAS EVIDENCE OF THE DEVICE OVERHEATING. 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. THIS REPORT IS TO ADDRESS THE OVERHEATING EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443596 ↗
• MalfunctionDec 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT 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 13061455 ↗
• MalfunctionOct 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SONOPET TIP 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 12657581 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A MINOR DELAY OF 1 MINUTE OCCURRED AS A RESULT OF TIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604066 ↗
• MalfunctionOct 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRANSPHENOIDAL PROCEDURE THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A MINOR DELAY OF A FEW MINUTES WAS REPORTED TO SWAP OUT THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10656956 ↗
• MalfunctionOct 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRANSPHENOIDAL PROCEDURE THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A MINOR DELAY WAS REPORTED OF A FEW MINUTES TO SWAP OUT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10656943 ↗
• MalfunctionAug 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRANSSPHENOIDAL RESECTION OF PITUITARY TUMOR SURGERY, THE BLADE/KNIFE BROKE. IT WAS ALSO REPORTED THAT CHARRING OCCURRED PRIOR TO THE BLADE/KNIFE BREAKING. IT WAS FURTHER REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT ADDRESSES THE INSTANCE OF THE BLADE/KNIFE BREAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10363353 ↗
• MalfunctionAug 4, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A TRANSSPHENOIDAL RESECTION OF PITUITARY TUMOR SURGERY, THE BLADE/KNIFE BROKE. IT WAS ALSO REPORTED THAT CHARRING OCCURRED PRIOR TO THE BLADE/KNIFE BREAKING. IT WAS FURTHER REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT ADDRESSES THE INSTANCE OF THE HEAT CAUSING CHARRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10363335 ↗