Articulator 00711810Recalls & reported problems
US Endoscopy · The Articulator injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995180874), received between Sep 27, 2022 and Dec 13, 2022 — classified as 3 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
Device problems
- Failure to Eject2
- Insufficient Device Problem Information1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2022Retraction Problem; Insufficient Device Problem Information; Retraction Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ARTICULATOR INJECTION NEEDLE WAS NOT OPERATING PROPERLY 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 15970259 ↗MalfunctionSep 27, 2022Failure to Eject; Failure to Eject
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE MULTIPLE OF THEIR ARTICULATOR INJECTION NEEDLES FAILED TO DEPLOY CORRECTLY 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 15491182 ↗MalfunctionSep 27, 2022Failure to Eject; Failure to Eject
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE MULTIPLE OF THEIR ARTICULATOR INJECTION NEEDLES FAILED TO DEPLOY CORRECTLY 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 15491119 ↗
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 · TerminatedVari-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
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- MAGNUM MN1820Bard Peripheral Vascular, Inc. · Biopsy needle1 recall37 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4022Olympus Medical Systems Corp. · Biopsy needle1 recall29 reports
- Interject M00518250Boston Scientific Corporation · Biopsy needle70 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.