Single Use Injector NM-401L-0525 (REF N6140530)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170422652), received between Mar 2, 2022 and Jul 19, 2024 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2024Failure to Charge; Failure to Charge

  THE PROCEDURE WAS CYSTOSCOPY WITH BOTOX INJECTION THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS A LITTLE DELAY AND NO ANESTHESIA INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785206 ↗
• MalfunctionJul 15, 2024Failure to Discharge; Failure to Discharge

  IT WAS REPORTED THAT THE INJECTOR AND SHEATH SET WERE UNABLE TO INJECT LIQUID. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE; HOWEVER, THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739883 ↗
• MalfunctionJun 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE SINGLE USE INJECTOR HAD RESISTANCE DURING AN INJECTION OF BOTOX OR DEXAMETHASONE AND WHILE DISENGAGING AND FLUSHING THE DEVICE, THE FLUID WENT OUT WITHOUT RESISTANCE. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS STOPPED 3 TIMES IN ORDER TO CHANGE OUT THE NEEDLE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19516034 ↗
• MalfunctionMay 27, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED TO OLYMPUS THEY EXPERIENCED RESISTANCE WHEN ENGAGING THE OLYMPUS 25 G NEEDLE TO INJECT BOTOX AND DEXAMETHASONE IN VOCAL CHORDS DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE HAD TO BE STOPPED THREE TIMES TO CHANGE THE NEEDLE WITH THE SAME PATIENT. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402410 ↗
• MalfunctionMay 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE SINGLE USE INJECTOR HAD RESISTANCE DURING AN INJECTION OF BOTOX OR DEXAMETHASONE AND WHILE DISENGAGING AND FLUSHING THE DEVICE, THE FLUID WENT OUT WITHOUT RESISTANCE. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS STOPPED 3 TIMES IN ORDER TO CHANGE OUT THE NEEDLE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19395901 ↗
• MalfunctionMay 23, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE SINGLE USE INJECTOR HAD RESISTANCE DURING AN INJECTION OF BOTOX OR DEXAMETHASONE AND WHILE DISENGAGING AND FLUSHING THE DEVICE, THE FLUID WENT OUT WITHOUT RESISTANCE. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS STOPPED 3 TIMES IN ORDER TO CHANGE OUT THE NEEDLE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388771 ↗
• MalfunctionJul 17, 2023Activation Failure; Activation Failure

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE INJECTOR LOCKS AND YOU CAN¿T INJECT ANYTHING WHEN YOU FULLY ENGAGE THE NEEDLE. SO, WE MUST USE A SECOND ONE AND WASTE WHAT WE ALREADY TRIED TO INJECT. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339407 ↗
• MalfunctionJul 8, 2022No Flow; No Flow

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A DIAGNOSTIC LARGE INTESTINE EXAMINATION PROCEDURE WHEN THE DEVICE WAS USED INSIDE THE PATIENT BODY, THE LIQUID DID NOT COME OUT AND WAS NOT SENT TO THE PATIENT BODY. ANOTHER DEVICE OF THE SAME MODEL NUMBER WAS TESTED OUTSIDE THE PATIENT BODY. THE SECOND DEVICE DID NOT EJECT ANY LIQUID EITHER. A THIRD DEVICE WAS USED AS REPLACEMENT AND THE PROCEDURE COMPLETED WITH NO MORE ISSUES. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960968 ↗
• MalfunctionMar 2, 2022No Flow; No Flow

  AS REPORTED, THE ENT DEVICE WAS REPORTED TO FAIL UPON INITIAL CLINICAL USE. THE OPERATOR CONNECTED THE NM-401L-0525 SINGLE USE INJECTOR AND TRIED TO PASS FLUID THROUGH THE NEEDLE, COULD NOT PUSH ANY FLUID, IT WAS BLOCKED. THE CUSTOMER TRIED THREE DIFFERENT INJECTORS FROM THIS LOT WITH NO SUCCESS. CUSTOMER DID NOT COMPLETE THE INJECTION PART OF THE CASE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED THIS REPORT IS RELATED TO REPORT WITH PATIENT IDENTIFIER (B)(6) AND (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654293 ↗
• MalfunctionMar 2, 2022No Flow; No Flow

  AS REPORTED, THE ENT DEVICE WAS REPORTED TO FAIL UPON INITIAL CLINICAL USE. THE OPERATOR CONNECTED THE NM-401L-0525 SINGLE USE INJECTOR AND TRIED TO PASS FLUID THROUGH THE NEEDLE, COULD NOT PUSH ANY FLUID, IT WAS BLOCKED. THE CUSTOMER TRIED THREE DIFFERENT INJECTORS FROM THIS LOT WITH NO SUCCESS. CUSTOMER DID NOT COMPLETE THE INJECTION PART OF THE CASE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED THIS REPORT IS RELATED TO REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654285 ↗
• MalfunctionMar 2, 2022No Flow; No Flow

  AS REPORTED, THE ENT DEVICE WAS REPORTED TO FAIL UPON INITIAL CLINICAL USE. THE OPERATOR CONNECTED THE NM-401L-0525 SINGLE USE INJECTOR AND TRIED TO PASS FLUID THROUGH THE NEEDLE, COULD NOT PUSH ANY FLUID, IT WAS BLOCKED. THE CUSTOMER TRIED THREE DIFFERENT INJECTORS FROM THIS LOT WITH NO SUCCESS. CUSTOMER DID NOT COMPLETE THE INJECTION PART OF THE CASE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS RELATED TO REPORT WITH PATIENT IDENTIFIER (B)(6)AND (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654280 ↗