Articulator 00711807Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00724995180850), received between Apr 28, 2022 and Jan 27, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K232826, K971842); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2023Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF THE ARTICULATOR INJECTION NEEDLE, THE NEEDLE TIP COULD NOT BE WITHDRAWN INTO THE DEVICE. ANOTHER ARTICULATOR INJECTION NEEDLE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254438 ↗
• MalfunctionJun 3, 2022Failure to Eject; Failure to Eject

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ARTICULATOR INJECTION NEEDLES FAILED TO DEPLOY CAUSING A PROCEDURE DELAY. THE USER FACILITY PERSONNEL USED AN ADDITIONAL DEVICE TO COMPLETE THE PROCEDURE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597477 ↗
• MalfunctionJun 2, 2022Failure to Eject; Failure to Eject

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ARTICULATOR INJECTION NEEDLE FAILED TO DEPLOY RESULTING IN A PROCEDURE POSTPONEMENT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14573132 ↗
• MalfunctionApr 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF AN INJECTION NEEDLE THE DEVICE WOULD NOT WITHDRAW THE NEEDLE. ANOTHER INJECTION NEEDLE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14242104 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232826, K971842. One submission often covers many models, so check the product and lot details in each record.

• Z-0289-2017 · May 18, 2016 · Terminated
  Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types o