Hyflex H825ASSTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D661H825ASST1), received between Dec 10, 2020 and Dec 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2020Break; Fracture; Break; Fracture

  ASSISTANT AT THE OFFICE SAID THAT THE DOCTOR PERFORMED A ROOT CANAL PROCEDURE ON A FEMALE PATIENT ABOUT (B)(6) ON (B)(6). AS THE ROOT CANAL WAS BEING DONE, THE TIP OF THE FILE BROKE BUT IT WAS RETRIEVED AND DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019153 ↗
• MalfunctionDec 10, 2020Break; Fracture; Break; Fracture

  ASSISTANT AT THE OFFICE SAID THAT THE DOCTOR PERFORMED A ROOT CANAL PROCEDURE ON A MALE PATIENT EITHER (B)(6) OR (B)(6)YEARS OLD. WHILE THE DOCTOR WAS PERFORMING THE ROOT CANAL, THE TIP OF THE FILE BROKE, BUT IT WAS NOT ABLE TO BE RETRIEVED, AND THE PIECE THAT BROKE WAS LEFT IN THE PATIENT'S CANAL. THE PATIENT DID NOT REPORT ANY DISCOMFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983935 ↗