Sonopet iQ 550025S310Recalls & reported problems
Stryker Corporation · 12cm iQ Barracuda · Class U
All models of Sonopet iQ (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327422443), received between Aug 26, 2021 and Sep 27, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Excessive Heating” (3 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
Device problems
- Excessive Heating3
- Overheating of Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2021Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating
IT WAS REPORTED THAT THE SLEEVE MELTED DUING A CRANIOTOMY PROCEDURE. 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 12532536 ↗MalfunctionAug 26, 2021Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP SLEEVE OVERHEATED AND MELTED DURING USE. IT WAS ALSO REPORTED THERE WAS A SLIGHT/MINOR DELAY 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 12370181 ↗MalfunctionAug 26, 2021Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP SLEEVE OVERHEATED AND MELTED DURING USE. IT WAS ALSO REPORTED THERE WAS A SLIGHT/MINOR DELAY 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 12370098 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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