iBur 5407-120-300Recalls & reported problems
Stryker Corporation · Hub · Class 2
All models of iBur (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327501308), received between Jul 3, 2024 and May 28, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095087 ↗MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO MEDICAL INTERVENTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095086 ↗MalfunctionFeb 21, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THAT DURING SURGERY, A RESIDUE WAS LEAKING FROM THE HUB. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21433325 ↗MalfunctionJan 9, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21118869 ↗MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING TESTING, IT WAS NOTED THAT A FLUID LIKE SUBSTANCE WAS LEAKING FROM THE HUB. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19668347 ↗
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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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