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Hyflex H8250415Recalls & reported problems

Coltene/Whaledent Inc · Hyflex CM 04/15 x 25mm File · Class 1

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 D661H82504151), received between Apr 2, 2020 and Apr 2, 2020 — classified as 1 malfunction.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    INITIAL INFORMATION PROVIDED 01/07/2020: "DOCTOR PURCHASED HYFLEX CM FILES. A 04/15 FILE BROKE." ADDITIONAL INFORMATION PROVIDED BY THE DENTAL OFFICE ON 03/23/2020: HOW WAS FILE BEING USED WHEN IT BROKE? IN ROTARY HANDPIECE. DID IT BREAK IN THE PATIENT'S MOUTH/TOOTH? YES, IN THE TOOTH. WAS THERE ANY INJURY? NO. WAS THE FILE ABLE TO BE RETRIEVED? NO. DID THE REMOVAL REQUIRE SURGICAL INTERVENTION? NO.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9916886 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.