Single Use Injector NM-400U-0425 (REF N6139730)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170422577), received between Nov 8, 2022 and Oct 31, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Activation, Positioning or Separation Problem

  OLYMPUS INJECTOR FORCE 25G NEEDLE WOULD NOT DEPLOY OUT OF SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435743 ↗
• MalfunctionNov 25, 2024

  INSERTED INJECTOR NEEDLE DOWN SCOPE, TRIED TO DEPLOY NEEDLE FROM SHEATH TO INJECT, BUT NEEDLE WOULD NOT COME OUT. REMOVED INJECTOR NEEDLE FROM SCOPE, ATTEMPTED TO DEPLOY NEEDLE OUTSIDE OF SCOPE, AND NEEDLE WOULD NOT DEPLOY EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771114 ↗
• MalfunctionJan 12, 2024

  INJECTION NEEDLE FAILED TO DEPLOY. DEVICE APPEARS TO BE MISSING A COMPONENT THAT CONNECTS THE NEEDLE TO THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502131 ↗
• MalfunctionAug 17, 2023

  NJECTORFORCE MAX/OLYMPUS SINGLE USE INJECTOR FAILED TO ADVANCE NEEDLE OUT OF THE DEVICE WHEN ASSISTANT ATTEMPTED TO ACTIVATE THE MECHANISM TO "NEEDLE OUT". NEW INJECTOR OPENED, TESTED THE FUNCTION ON THIS NEW DEVICE PRIOR TO INSERTING INTO GASTROSCOPE- DEVICE WORKING CORRECTLY/NEEDLE WAS ADVANCING PROPERLY WHEN MECHANISM INITIATED. DEVICE INSERTED INTO SCOPE, DEVICE CATHETER IN VIEW ON SCREEN, DEVICE FAILED TO WORK AGAIN. RESISTANCE MET WHEN TRYING TO ADVANCE THE NEEDLE INTO VIEW. THIRD INJECTOR OPENED, TESTED MECHANISM- CONFIRMED IT WAS WORKING CORRECTLY, INSERTED INTO SCOPE AND THIS TIME NEEDLE DEVICE ADVANCING PROPERLY AND INJECTION WAS ABLE TO BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563468 ↗
• MalfunctionJun 27, 2023Activation, Positioning or Separation Problem

  NEEDLE FLUSHED WITH TATTOO. NEEDLE WAS RETRACTED. 25GA X 4MM INJECTION NEEDLE WAS INTRODUCED IN THE SCOPE. UPON ATTEMPTING TO USE THE NEEDLE IT WOULD NOT DEPLOY. MULTIPLE ATTEMPTS TO REPOSITION AND DEPLOY HAVE BEEN ATTEMPTED. THE DEVICE WAS REMOVED FROM THE SCOPE AND WOULD NOT DEPLOY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208563 ↗
• MalfunctionJan 20, 2023Failure to Deliver; Failure to Infuse; Infusion or Flow Problem; Failure to Deliver; Failure to Infuse; Infusion or Flow Problem

  USER FACILITY REPORTED WITH AN ISSUE OF "INK SPREAD EVERYWHERE EXCEPT DESIRED LOCATION". CUSTOMER STATED "THE INK IS SPREADING EVERYWHERE EXCEPT WHERE THE INK NEEDS TO GO. ACCORDING TO THE REPORTER, THE ISSUE OCCURRED DURING A STANDARD PROCEDURE FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . PER THE REPORT , THE PROBLEM OCCURRED/FAILED TWICE ON THE SAME MODEL WITH THE SAME LOT (21V). NO FURTHER INFORMATION PROVIDED. THIS EVENT INCLUDES TWO (2 ) REPORTS TO CAPTURE THE TWO REPORTED FAILURE: REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425, LOT 21V). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425, LOT 21V). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425, LOT 21V).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218469 ↗
• MalfunctionJan 20, 2023Failure to Deliver; Failure to Infuse; Infusion or Flow Problem; Failure to Deliver; Failure to Infuse; Infusion or Flow Problem

  USER FACILITY REPORTED WITH AN ISSUE OF "INK SPREAD EVERYWHERE EXCEPT DESIRED LOCATION". CUSTOMER STATED "THE INK IS SPREADING EVERYWHERE EXCEPT WHERE THE INK NEEDS TO GO. ACCORDING TO THE REPORTER, THE ISSUE OCCURRED DURING A STANDARD PROCEDURE FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . PER THE REPORT , THE PROBLEM OCCURRED/FAILED TWICE ON THE SAME MODEL WITH THE SAME LOT (21V). NO FURTHER INFORMATION PROVIDED. THIS EVENT INCLUDES TWO (2 ) REPORTS TO CAPTURE THE TWO REPORTED FAILURE: REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425, LOT 21V). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425, LOT 21V). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425, LOT 21V).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218449 ↗
• MalfunctionJan 18, 2023Failure to Deliver; Failure to Infuse; Infusion or Flow Problem; Failure to Deliver; Failure to Infuse; Infusion or Flow Problem

  USER FACILITY REPORTED WITH AN ISSUE OF "INK SPREADING". CUSTOMER STATED "THE INK IS SPREADING EVERYWHERE EXCEPT WHERE THE INK NEEDS TO GO. ACCORDING TO THE REPORTER, THE ISSUE OCCURRED DURING A STANDARD PROCEDURE FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . THIS EVENT INCLUDES 3 REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 1YV). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 1ZV). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 07V 20). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 1ZV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16192141 ↗
• MalfunctionJan 18, 2023Failure to Deliver; Failure to Infuse; Infusion or Flow Problem; Failure to Deliver; Failure to Infuse; Infusion or Flow Problem

  USER FACILITY REPORTED WITH AN ISSUE OF "INK SPREADS". CUSTOMER STATED "THE INK IS SPREADING EVERYWHERE EXCEPT WHERE THE INK NEEDS TO GO. ACCORDING TO THE REPORTER, THE ISSUE OCCURRED DURING A STANDARD PROCEDURE FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . THIS EVENT INCLUDES 3 REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 1YV). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 1ZV). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 07V 20). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 1YV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16191993 ↗
• MalfunctionJan 17, 2023Failure to Align; Failure to Align

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE INJECTOR WAS NOT INJECTING LIQUID PROPERLY INTO THE TARGET TISSUE. THE ISSUE OCCURRED DURING THE DIAGNOSTIC PROCEDURE (COLONOSCOPY), AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184021 ↗
• MalfunctionJan 17, 2023Failure to Align; Failure to Align

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE INJECTOR WAS NOT INJECTING LIQUID PROPERLY INTO THE TARGET TISSUE. THE ISSUE OCCURRED DURING THE DIAGNOSTIC PROCEDURE (COLONOSCOPY), AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184003 ↗
• MalfunctionNov 8, 2022Mechanics Altered; Activation Problem

  NEEDLE WOULD NOT COME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754460 ↗