Single Use Injector NM-401L-0425 (REF N6140330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04953170422638), received between Dec 2, 2021 and Feb 4, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (9 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THE SUBJECT FAILED TO INJECT. THE ISSUE OCCURRED BEFORE SEDATION FOR THERAPEUTIC THROAT INJECTIONS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307275 ↗
• MalfunctionJan 27, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THE SINGLE USE INJECTOR WHEN DEPLOYED WOULD NOT ALLOW ANY MEDICATION TO GO THROUGH THE PROBE. THE ISSUE OCCURRED BEFORE SEDATION DURING A THERAPEUTIC TRANS NASAL STEROID INJECTION PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITH LESS THAN A 30-MINUTE DELAY. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242951 ↗
• MalfunctionJan 23, 2025No Flow; No Flow

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21222954 ↗
• MalfunctionJan 23, 2025No Flow; No Flow

  IT WAS REPORTED THE SUBJECT DEVICE HAD NO FLUID COMING OUT OF THE INJECTION NEEDLE. ADDITIONALLY REPORTED, THERE WAS A KINK FOUND IN THE TUBING PART. THIS ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217227 ↗
• MalfunctionJul 3, 2024Defective Component; Defective Component

  IT WAS REPORTED THE SINGLE USE INJECTOR FAILED TO DELIVER FLUID DUE TO A CLOGGED TIP. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC INJECTION SCLEROTHERAPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF ANY DELAYS, INJURY, OR DEATH. THE PATIENT WAS NOT UNDER ANESTHESIA AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671404 ↗
• MalfunctionJun 18, 2024Defective Component; Defective Component

  IT WAS REPORTED THE SINGLE USE INJECTOR FAILED TO DELIVER FLUID DUE TO A CLOGGED TIP. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC INJECTION SCLEROTHERAPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19561454 ↗
• MalfunctionAug 24, 2023Failure to Deliver; Failure to Deliver

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT WHEN SINGLE USE INJECTOR, THE NEEDLE WAS ENGAGED, AND THE SOLUTION WOULD NOT COME OUT OF THE SYRINGE DURING THE THERAPEUTIC LARYNGEAL INJECTION PROCEDURE. THE INTENDED PROCEDURE WAS PERFORMED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO DELAY NOR PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS LINKED TO PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17620301 ↗
• MalfunctionAug 21, 2023Failure to Deliver; Failure to Deliver

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT WHEN SINGLE USE INJECTOR, THE NEEDLE WAS ENGAGED, AND THE SOLUTION WOULD NOT COME OUT OF THE SYRINGE DURING THE THERAPEUTIC LARYNGEAL INJECTION PROCEDURE. THE INTENDED PROCEDURE WAS PERFORMED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO DELAY NOR PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17582139 ↗
• MalfunctionAug 21, 2023Failure to Deliver; Failure to Deliver

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT WHEN SINGLE USE INJECTOR, THE NEEDLE WAS ENGAGED, AND THE SOLUTION WOULD NOT COME OUT OF THE SYRINGE DURING THE THERAPEUTIC LARYNGEAL INJECTION PROCEDURE. THE INTENDED PROCEDURE WAS PERFORMED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO DELAY NOR PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17582031 ↗
• MalfunctionAug 21, 2023Failure to Deliver; Failure to Deliver

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT WHEN SINGLE USE INJECTOR, THE NEEDLE WAS ENGAGED, AND THE SOLUTION WOULD NOT COME OUT OF THE SYRINGE DURING THE THERAPEUTIC LARYNGEAL INJECTION PROCEDURE. THE INTENDED PROCEDURE WAS PERFORMED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO DELAY NOR PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17581922 ↗
• MalfunctionAug 21, 2023Failure to Deliver; Failure to Deliver

  THIS REPORT IS LINKED TO PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17581868 ↗
• MalfunctionAug 20, 2023Failure to Prime; Failure to Prime

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE INJECTOR WAS WHEN NEEDLE WAS ENGAGED SOLUTION WOULD NOT COME OUT OF THE SYRINGE DURING THE THERAPEUTIC LARYNGEAL INJECTION PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17581223 ↗
• MalfunctionAug 9, 2023Mechanical Problem; Failure to Infuse; Mechanical Problem; Failure to Infuse

  OLYMPUS COMPANY REPRESENTATIVE REPORTED THAT THE TWO NM-401L-0425 NEEDLES WERE NOT INJECTING. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. PER THE REPORT, TWO OF THE PACK OF FIVE WERE USED HOWEVER, IT WAS NOT INJECTING. A DIFFERENT LOT NUMBER WAS TRIED AND WORKED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS RELATED TO REPORT WITH PATIENT IDENTIFIER (B)(6) ( 2 OF 2 ) - NEEDLE THAT WAS NOT INJECTING DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495592 ↗
• MalfunctionJul 21, 2023Failure to Fire; Failure to Fire

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE INJECTOR WAS NOT ABLE TO INJECT WHEN NEEDLE WAS DEPLOYED. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. NO REPLACEMENT DEVICE WAS AVAILABLE. THE PROCEDURE WAS POSTPONED AND RESCHEDULED. THERE WERE NO REPORTS OF PATIENT DEATH, INJURY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374122 ↗
• MalfunctionDec 2, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THE "NM-401L-0425 NEEDLE WON'T PUSH SOLUTION THOUGH THE SYRINGE WHEN NEEDLE IS ENGAGED". ACCORDING TO THE REPORTER, THIS HAPPENED TWICE WITH THIS LOT NUMBER (24V) AND WITH ANOTHER LOT (23V). THE INTENDED PROCEDURE ACCORDING TO THE REPORT WAS COMPLETED . NO HARM REPORTED , NO USER INJURY REPORTED DUE TO THE EVENT. SYRINGE THIS EVENT INCLUDES 3 REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6). (NM-401L-0425 LOT 24V). REPORT WITH PATIENT IDENTIFIER (B)(6). (NM-401L-0425 LOT 24V) . REPORT WITH PATIENT IDENTIFIER (B)(6). (NM-401L-0425 LOT 23V). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6). (NM-401L-0425 LOT 24V) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15901280 ↗
• MalfunctionDec 1, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THE "NM-401L-0425 NEEDLE WON'T PUSH SOLUTION THOUGH THE SYRINGE WHEN NEEDLE IS ENGAGED". ACCORDING TO THE REPORTER, THIS HAPPENED TWICE WITH THIS LOT NUMBER (24V) AND WITH ANOTHER LOT (23V). THE INTENDED PROCEDURE ACCORDING TO THE REPORT WAS COMPLETED . NO HARM REPORTED , NO USER INJURY REPORTED DUE TO THE EVENT. SYRINGE THIS EVENT INCLUDES 3 REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-401L-0425 LOT 24V). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-401L-0425 LOT 24V) . REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-401L-0425 LOT 23V). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-401L-0425 LOT 23V).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15898772 ↗
• MalfunctionDec 1, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THE "NM-401L-0425 NEEDLE WON'T PUSH SOLUTION THOUGH THE SYRINGE WHEN NEEDLE IS ENGAGED". ACCORDING TO THE REPORTER, THIS HAPPENED TWICE WITH THIS LOT NUMBER (24V) AND WITH ANOTHER LOT (23V). THE INTENDED PROCEDURE ACCORDING TO THE REPORT WAS COMPLETED . NO HARM REPORTED , NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES 3 REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-401L-0425 LOT 24V). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-401L-0425 LOT 24V) . REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-401L-0425 LOT 23V). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-401L-0425 LOT 24V).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15898445 ↗
• MalfunctionAug 3, 2022Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC INJECTION SCLEROTHERAPY (EIS) PROCEDURE, THE SUBJECT DEVICE WAS UNABLE TO DELIVER THE DRUG SOLUTION TO THE ESOPHAGEAL VENOUS FLOW. THE SUBJECT DEVICE WAS REPORTEDLY INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. THE ISSUE PERSISTED EVEN AFTER REPLACING THE DEVICE TWICE WITH THE SAME MODEL, DURING THE SAME PROCEDURE. THE INTENDED PROCEDURE WAS CANCELLED. THERE WAS NO HEALTH HAZARD TO THE PATIENT DUE TO THE EVENT. THERE WAS NO REPORT OF USER INJURY DUE TO THE EVENT. THE ISSUE WITH DEVICE #1 IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH DEVICE #2 IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH DEVICE #3, ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160383 ↗
• MalfunctionAug 3, 2022Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC INJECTION SCLEROTHERAPY (EIS) PROCEDURE, THE SUBJECT DEVICE WAS UNABLE TO DELIVER THE DRUG SOLUTION TO THE ESOPHAGEAL VENOUS FLOW. THE SUBJECT DEVICE WAS REPORTEDLY INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. THE ISSUE PERSISTED EVEN AFTER REPLACING THE DEVICE TWICE WITH THE SAME MODEL, DURING THE SAME PROCEDURE. THE INTENDED PROCEDURE WAS CANCELLED. THERE WAS NO HEALTH HAZARD TO THE PATIENT DUE TO THE EVENT. THERE WAS NO REPORT OF USER INJURY DUE TO THE EVENT. THE ISSUE WITH DEVICE #1 IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH DEVICE #2, ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH DEVICE #3 IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157590 ↗
• MalfunctionAug 3, 2022Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC INJECTION SCLEROTHERAPY (EIS) PROCEDURE, THE SUBJECT DEVICE WAS UNABLE TO DELIVER THE DRUG SOLUTION TO THE ESOPHAGEAL VENOUS FLOW. THE SUBJECT DEVICE WAS REPORTEDLY INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. THE ISSUE PERSISTED EVEN AFTER REPLACING THE DEVICE TWICE WITH THE SAME MODEL, DURING THE SAME PROCEDURE. THE INTENDED PROCEDURE WAS CANCELLED. THERE WAS NO HEALTH HAZARD TO THE PATIENT DUE TO THE EVENT. THERE WAS NO REPORT OF USER INJURY DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH DEVICE #1, WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH DEVICE #2 IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH DEVICE #3 IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157393 ↗
• MalfunctionMay 25, 2022Mechanical Problem; Mechanical Problem

  OLYMPUS REPRESENTATIVE (REP.) REPORTED THE NEEDLE WITH PART NUMBER NM-401L-0425 WAS UNABLE TO INJECT AFTER IT HAD EXTENDED THE NEEDLE. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. ACCORDING TO THE REPORTER (REP.) THERE WAS NO PATIENT INVOLVED AND NO PATIENT INJURY REPORTED. CUSTOMER IS RETURNING THE WHOLE REST OF THE BOX OF NEEDLES. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14494209 ↗
• MalfunctionMay 3, 2022Mechanical Problem; No Flow; Mechanical Problem; No Flow

  IT WAS REPORTED DURING A THERAPEUTIC PROCEDURE WITH NM-401L-0425 DEVICE, WHEN SENDING LIQUID FROM A SYRINGE, THE LIQUID CANNOT BE SENT TO THE LIQUID SENDING PORT. THE DEVICE WAS REPLACED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270410 ↗
• MalfunctionFeb 18, 2022Mechanical Problem; Mechanical Problem

  AS REPORTED, WHEN THE NEEDLE IS EXTENDED OUT FLUID IT CANNOT BE PUSHED THROUGH, WHEN NEEDLE IS IN THE IN POSITION FLUID CAN BE PUSHED THROUGH. DEVICE OPERATING BACKWARDS REPORTED OCA SALES REPRESENTATIVE. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY WAS REPORTED. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13556880 ↗
• MalfunctionFeb 18, 2022Mechanical Problem; Mechanical Problem

  AS REPORTED, WHEN NEEDLE IS EXTENDED OUT FLUID CANNOT BE PUSHED THROUGH, WHEN NEEDLE IS IN THE IN POSITION FLUID CAN BE PUSHED THROUGH. DEVICE OPERATING BACKWARDS REPORTED OCA SALES REPRESENTATIVE. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE IS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13556746 ↗
• MalfunctionJan 7, 2022Failure to Deliver; No Flow; Failure to Deliver; No Flow

  AS REPORTED, DEVICE WAS REPORTED TO FAIL UPON CLINICAL USE. WHEN OPERATORS CONNECT SYRINGE TO THE LUER LOCK THEY ARE ABLE TO PUSH FLUID THROUGH, THEY LOCK THE LUER IN PLACE WHICH PUSHES THE NEEDLE OUT THE DISTAL TIP OF THE NEEDLE BUT NO FLUID EXITS OUT OF THE NEEDLE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13194834 ↗