Single Use Injector NM-401L-0423 (REF N3048440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170454035), received between Jan 18, 2023 and May 1, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THE SUBJECT DEVICE NEEDLE COULD NOT GO OUT WHEN WANTED TO INJECT. THE ISSUE OCCURRED DURING A COLON POLYPECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941386 ↗
• MalfunctionOct 28, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED, THE SINGLE-USE INJECTOR WAS UNABLE TO DELIVER FLUID. WHEN THE USER TRIED TO EXTEND THE NEEDLE AND INJECT LOCALLY, IT DID NOT WORK. WHEN THE NEEDLE WAS RETRACTED, THE FLUID THEN BEGAN TO DRIP OUT. THE PROCEDURE WAS COMPLETED WITH THE THIRD INJECTOR THEY USED. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543425 ↗
• MalfunctionSep 15, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR HAD NO SOLUTION COMING OUT OF THE TIP OF THE NEEDLE. IT WAS ALSO REPORTED THAT WHEN THE TIP OF THE NEEDLE WAS ONLY PARTIALLY EXTENDED, THE LIQUID CAME OUT. SALINE CAME OUT EITHER WAY. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20221173 ↗
• MalfunctionSep 12, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR HAD NO SOLUTION COMING OUT OF THE TIP OF THE NEEDLE. IT WAS ALSO REPORTED THAT WHEN THE TIP OF THE NEEDLE WAS ONLY PARTIALLY EXTENDED, THE LIQUID CAME OUT. SALINE CAME OUT EITHER WAY. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200616 ↗
• MalfunctionJul 15, 2024No Device Output; No Flow; No Device Output; No Flow

  IT WAS REPORTED, THE INJECTOR¿S SALINE SOLUTION WAS NOT COMING OUT OF THE NEEDLE SNEATH. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742081 ↗
• MalfunctionApr 3, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE LIQUID FROM THE TIP OF THE INJECTOR AND SHEATHSET ((B)(6)) COULD NOT BE DELIVERED. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038794 ↗
• MalfunctionOct 16, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE INJECTOR LIQUID DID NOT COME THROUGH WHILE THE NEEDLE WAS OUT. WHEN THE NEEDLE WAS IN, THE LIQUID WOULD COME THROUGH. THERE WAS NO PROBLEM REMOVING THE NEEDLE. THE EVENT OCCURRED AGAIN WITH ANOTHER NEEDLE. THE ISSUE WAS FOUND DURING THE THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THE PROCEDURE WAS DELAYED ABOUT FIVE MINUTES WHILE CHANGING THE NEEDLE. THE PROCEDURE WAS FINISHED WITH A SIMILAR NEEDLE WHICH WORKED NORMALLY. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17942412 ↗
• MalfunctionJan 18, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED AT PREPARATION FOR USE (BEFORE PROCEDURE) FOR A THERAPEUTIC GASTRIC ULCER (BLEEDING CASE); THE NURSE INSPECTED, TESTED THE INJECTOR AND FOUND NO PROBLEM. HOWEVER, DURING THE PROCEDURE, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTED THE ADRENALINE SOLUTION AND THE SOLUTION ABLE TO FLOW, HOWEVER, FOR THE SECOND TIME, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION GOT STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. SECOND INJECTOR WAS OPENED , HOWEVER, SAME ISSUE TRANSPIRED. WHEN THE SOLUTION WAS INJECTED, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION ABLE TO FLOW FOR THREE TIMES. HOWEVER, FOR THE FOURTH TIME, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION GOT STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. THE USER HOWEVER, WAS ABLE TO CONTINUE THE PROCEDURE . THE INTENDED PROCEDURE WAS COMPLETED WITH NO HARM REPORTED. THE PATIENT WAS REPORTED TO BE IN GOOD STATUS. NO PATIENT HARM, NO U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200448 ↗
• MalfunctionJan 18, 2023Mechanical Problem; Failure to Infuse; No Flow; Mechanical Problem; Failure to Infuse; No Flow

  IT WAS REPORTED AT PREPARATION FOR USE (BEFORE PROCEDURE) FOR A THERAPEUTIC GASTRIC ULCER (BLEEDING CASE), THE NURSE INSPECTED, TESTED THE INJECTOR AND FOUND NO PROBLEM. HOWEVER, DURING THE PROCEDURE, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTED THE ADRENALINE SOLUTION AND WAS ABLE TO FLOW. HOWEVER, FOR THE SECOND TIME, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTED ADRENALINE SOLUTION AND THE SOLUTION GOT STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. THE NURSE TRIED TO EXAMINE AND TEST THE INJECTOR AFTER TAKING IT OUT FROM THE SCOPE, HOWEVER, THE SAME ISSUE TRANSPIRED. A SECOND INJECTOR (SIMILAR DEVICE) WAS OPENED TO CONTINUE THE PROCEDURE, HOWEVER, THE SECOND INJECTOR HAD THE SAME ISSUE. THE INTENDED PROCEDURE HOWEVER, WAS COMPLETED USING THE SECOND INJECTOR AND WITH NO HARM REPORTED. THE PATIENT WAS REPORTED TO BE IN GOOD STATUS. NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO (2 ) REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (FIRST INJECTOR) REPORT WITH PATIENT IDENTIFIER (B)(6) (SECOND INJECTOR) THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200398 ↗