Hu-Friedy UI30SDXTTBRecalls & reported problems
Hu-Friedy Mfg. CO., LLC · XT Triple Bend Swivel Direct Flow 30K · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889950075675), received between May 8, 2024 and May 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2024Break; Break
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TIP OF THEIR XT TRIPLE BEND INSERT BROKE OFF INTO THE PATIENT'S MOUTH. THE TIP OF THE DEVICE WAS UNABLE TO BE LOCATED HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FOLLOWING THE PROCEDURE, THE PATIENT WAS ADVISED TO RECEIVE X-RAYS. THE TIP OF THE DEVICE WAS OBSERVED IN THE X-RAYS. IT IS UNKNOWN IF OR HOW THE TIP WAS REMOVED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19272639 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.