Single Use Injector NM-401L-0423 (UDI 04953170260018)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04953170260018), received between Jan 7, 2022 and May 30, 2025 — classified as 27 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Failure to Deliver; Activation Failure; Failure to Deliver; Activation Failure

  IT WAS REPORTED THAT DURING SEVERAL PROCEDURES INVOLVING THE USE OF SUBJECT DEVICE AND LIQUID MEDICATION, THE DOCTOR WAS ABLE TO INJECT THE LIQUID, BUT THE TIP OF THE NEEDLE DOES NOT EMERGE AS EXPECTED. IN OTHER INSTANCES, THE NEEDLE TIP EMERGES, BUT THE LIQUID MEDICATION CANNOT BE ADMINISTERED. THE DOCTOR SUSPECTS THAT THE MEDICATION MAY BE TOO VISCOUS, CAUSING THE NEEDLE TO BECOME CLOGGED. DUE TO THIS ISSUE, THE DOCTOR HAD TO USE 4 TO 5 NEEDLES TO COMPLETE A SINGLE OPERATION. NO OTHER PROCEDURAL INFORMATION HAS BEEN PROVIDED. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 7 OF 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119837 ↗
• MalfunctionMay 30, 2025Failure to Deliver; Activation Failure; Failure to Deliver; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119736 ↗
• MalfunctionMay 30, 2025Failure to Deliver; Activation Failure; Failure to Deliver; Activation Failure

  IT WAS REPORTED THAT DURING SEVERAL PROCEDURES INVOLVING THE USE OF SUBJECT DEVICE AND LIQUID MEDICATION, THE DOCTOR WAS ABLE TO INJECT THE LIQUID, BUT THE TIP OF THE NEEDLE DOES NOT EMERGE AS EXPECTED. IN OTHER INSTANCES, THE NEEDLE TIP EMERGES, BUT THE LIQUID MEDICATION CANNOT BE ADMINISTERED. THE DOCTOR SUSPECTS THAT THE MEDICATION MAY BE TOO VISCOUS, CAUSING THE NEEDLE TO BECOME CLOGGED. DUE TO THIS ISSUE, THE DOCTOR HAD TO USE 4 TO 5 NEEDLES TO COMPLETE A SINGLE OPERATION. NO OTHER PROCEDURAL INFORMATION HAS BEEN PROVIDED. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 5 OF 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119734 ↗
• MalfunctionMay 30, 2025Failure to Deliver; Activation Failure; Failure to Deliver; Activation Failure

  IT WAS REPORTED THAT DURING SEVERAL PROCEDURES INVOLVING THE USE OF SUBJECT DEVICE AND LIQUID MEDICATION, THE DOCTOR WAS ABLE TO INJECT THE LIQUID, BUT THE TIP OF THE NEEDLE DOES NOT EMERGE AS EXPECTED. IN OTHER INSTANCES, THE NEEDLE TIP EMERGES, BUT THE LIQUID MEDICATION CANNOT BE ADMINISTERED. THE DOCTOR SUSPECTS THAT THE MEDICATION MAY BE TOO VISCOUS, CAUSING THE NEEDLE TO BECOME CLOGGED. DUE TO THIS ISSUE, THE DOCTOR HAD TO USE 4 TO 5 NEEDLES TO COMPLETE A SINGLE OPERATION. NO OTHER PROCEDURAL INFORMATION HAS BEEN PROVIDED. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 4 OF 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119731 ↗
• MalfunctionMay 30, 2025Failure to Deliver; Activation Failure; Failure to Deliver; Activation Failure

  IT WAS REPORTED THAT DURING SEVERAL PROCEDURES INVOLVING THE USE OF SUBJECT DEVICE AND LIQUID MEDICATION, THE DOCTOR WAS ABLE TO INJECT THE LIQUID, BUT THE TIP OF THE NEEDLE DOES NOT EMERGE AS EXPECTED. IN OTHER INSTANCES, THE NEEDLE TIP EMERGES, BUT THE LIQUID MEDICATION CANNOT BE ADMINISTERED. THE DOCTOR SUSPECTS THAT THE MEDICATION MAY BE TOO VISCOUS, CAUSING THE NEEDLE TO BECOME CLOGGED. DUE TO THIS ISSUE, THE DOCTOR HAD TO USE 4 TO 5 NEEDLES TO COMPLETE A SINGLE OPERATION. NO OTHER PROCEDURAL INFORMATION HAS BEEN PROVIDED. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 3 OF 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119729 ↗
• MalfunctionMay 30, 2025Failure to Deliver; Activation Failure; Failure to Deliver; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119724 ↗
• MalfunctionMay 30, 2025Failure to Deliver; Activation Failure; Failure to Deliver; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119710 ↗
• MalfunctionAug 22, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED, THAT THE SINGLE-USE INJECTOR WAS UNABLE TO INJECT LIQUID AFTER BEING EXTENDED. ATTEMPTED TO WITHDRAW THE NEEDLE TO EXIT THE SCOPE AND WAS UNABLE TO RETRIEVE IT. THE ISSUE OCCURRED, DURING A THERAPEUTIC ESOPHAGEAL STENT IMPLANTATION PROCEDURE. WHICH WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032997 ↗
• MalfunctionJun 28, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THE SINGLE USE INJECTOR GOT CLOGGED DURING THE BEGINNING OF A DIAGNOSTIC POLYPECTOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632817 ↗
• MalfunctionJun 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED, THE SINGLE USE INJECTOR HAD VERY STRONG RESISTANCE AT THE SYRINGE AND WOULD NOT INJECT THE SOLUTION AT ALL THROUGH THE SYRINGE. THE ISSUE OCCURRED DURING A PRODUCT DEMONSTRATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566823 ↗
• MalfunctionJun 5, 2024Failure to Deliver; Failure to Eject; Failure to Deliver; Failure to Eject

  IT WAS REPORTED THE SINGLE USE INJECTOR WAS UNABLE TO DELIVER FLUID OR EJECT THE NEEDLE. THE ISSUE OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC INTRAGASTRIC SURGERY. 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 19473264 ↗
• MalfunctionApr 10, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THE SINGLE USE INJECTOR HAD BLOCKAGE AND THE SOLUTION COULD NOT BE INJECTED. THE ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080948 ↗
• MalfunctionApr 5, 2024Complete Blockage; Failure to Discharge; Complete Blockage; Failure to Discharge

  IT WAS REPORTED THAT THE OLYMPUS INJECTION NEEDLE EXPERIENCED AN INJECTION FAILURE DURING MULTIPLE CASES. REPORTEDLY, THE NURSE HAD PRIMED THE NEEDLE PRIOR TO USE WITHOUT ISSUE. HOWEVER, AFTER INSERTING THE NEEDLE INTO THE SCOPE, IT DEPLOYED, BUT NO SOLUTION WAS INJECTED DUE TO A BLOCKAGE. THIS EVENT WAS NOTED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048267 ↗
• MalfunctionApr 4, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE OLYMPUS INJECTION NEEDLE EXPERIENCED AN INJECTION FAILURE DURING MULTIPLE CASES. REPORTEDLY, THE NURSE HAD PRIMED THE NEEDLE PRIOR TO USE WITHOUT ISSUE. HOWEVER, AFTER INSERTING THE NEEDLE INTO THE SCOPE, IT DEPLOYED, BUT NO SOLUTION WAS INJECTED DUE TO A BLOCKAGE. THIS EVENT WAS NOTED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICES WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048189 ↗
• MalfunctionApr 4, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE OLYMPUS INJECTION NEEDLE EXPERIENCED AN INJECTION FAILURE DURING MULTIPLE CASES. REPORTEDLY, THE NURSE HAD PRIMED THE NEEDLE PRIOR TO USE WITHOUT ISSUE. HOWEVER, AFTER INSERTING THE NEEDLE INTO THE SCOPE, IT DEPLOYED, BUT NO SOLUTION WAS INJECTED DUE TO A BLOCKAGE. THIS EVENT WAS DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICES WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047124 ↗
• MalfunctionApr 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE OLYMPUS INJECTION NEEDLE EXPERIENCED AN INJECTION FAILURE DURING MULTIPLE CASES. REPORTEDLY, THE NURSE HAD PRIMED THE NEEDLE PRIOR TO USE WITHOUT ISSUE. HOWEVER, AFTER INSERTING THE NEEDLE INTO THE SCOPE, IT DEPLOYED, BUT NO SOLUTION WAS INJECTED DUE TO A BLOCKAGE. THIS EVENT WAS NOTED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICES WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19029506 ↗
• MalfunctionMar 31, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE OLYMPUS INJECTION NEEDLE EXPERIENCED AN INJECTION FAILURE DURING MULTIPLE CASES. REPORTEDLY, THE NURSE HAD PRIMED THE NEEDLE PRIOR TO USE WITHOUT ISSUE. HOWEVER, AFTER INSERTING THE NEEDLE INTO THE SCOPE, IT DEPLOYED, BUT NO SOLUTION WAS INJECTED DUE TO A BLOCKAGE. THIS EVENT WAS NOTED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICES WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009425 ↗
• MalfunctionMar 29, 2024Failure to Discharge; Failure to Discharge

  IT WAS REPORTED THAT THE OLYMPUS INJECTION NEEDLE EXPERIENCED AN INJECTION FAILURE DURING MULTIPLE CASES. REPORTEDLY, THE NURSE HAD PRIMED THE NEEDLE PRIOR TO USE WITHOUT ISSUE. HOWEVER, AFTER INSERTING THE NEEDLE INTO THE SCOPE, IT DEPLOYED, BUT NO SOLUTION WAS INJECTED DUE TO A BLOCKAGE. THE ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICES WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006113 ↗
• MalfunctionMar 28, 2024Failure to Discharge; Failure to Discharge

  IT WAS REPORTED THAT THE OLYMPUS INJECTION NEEDLE EXPERIENCED AN INJECTION FAILURE DURING MULTIPLE CASES. REPORTEDLY, THE NURSE HAD PRIMED THE NEEDLE PRIOR TO USE WITHOUT ISSUE. HOWEVER, AFTER INSERTING THE NEEDLE INTO THE SCOPE, IT DEPLOYED, BUT NO SOLUTION WAS INJECTED DUE TO A BLOCKAGE. THIS EVENT WAS NOTED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICES WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996069 ↗
• MalfunctionMar 15, 2024Failure to Discharge; Failure to Discharge

  IT WAS REPORTED, THE INJECTOR AND SHEATH SET WAS PRIMED HOWEVER WHEN THE DOCTOR TRIED TO INJECT THERE WAS A BLOCKAGE AND THE SOLUTION COULDN¿T BE INJECTED. THE ISSUE OCCURRED DURING A THERAPEUTIC OESOPHAGO-GASTRO-DUODENOSCOPY (OGD) WITH SCLEROTHERAPY. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTOR AND SHEATH SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918080 ↗
• MalfunctionMar 15, 2024Failure to Discharge; Failure to Eject; Failure to Discharge; Failure to Eject

  IT WAS REPORTED, THE INJECTOR AND SHEATH SET WAS PRIMED HOWEVER WHEN THE DOCTOR TRIED TO INJECT THERE WAS A BLOCKAGE AND THE SOLUTION COULDN¿T BE INJECTED. THE ISSUE OCCURRED DURING A THERAPEUTIC OESOPHAGO-GASTRO-DUODENOSCOPY (OGD) WITH SCLEROTHERAPY. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTOR AND SHEATH SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918014 ↗
• 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 17942465 ↗
• MalfunctionNov 17, 2022No Device Output; No Device Output

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC ENDOSCOPY PROCEDURE, THE NURSE OPENED THE DEVICE, AND INTRODUCED THE DEVICE IN THE INSTRUMENT CHANNEL. HOWEVER, THE DEVICE INJECTOR COULD NOT INJECT THE LIQUID INTO THE TARGET TISSUE AS THE INJECTOR WAS COVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. NO OTHER DEVICE WAS REPLACED DURING THIS PROCEDURE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816575 ↗
• MalfunctionJul 12, 2022Break; Retraction Problem; Break; Retraction Problem

  A USER FACILITY REPORTED TO OLYMPUS, THE SINGLE USE INJECTOR WAS UNABLE TO INJECT WHEN NEEDLE WAS OUT. THE EVENT OCCURRED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE INJECTOR WAS TESTED IN AND OUT OF THE PATIENT BUT SHOWED THE SAME RESULTS. ACCORDING TO THE REPORT, INJECTION WAS POSSIBLE WHEN THE NEEDLE WAS RETRACTED, AND A 2ND NEEDLE WAS USED WITH THE SAME RESULT. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) FOR THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983921 ↗
• MalfunctionJun 7, 2022Mechanical Problem; No Flow; Mechanical Problem; No Flow

  IT WAS REPORTED THAT THE LIQUID DID NOT COME OUT FROM THE NEEDLE (TWO NEEDLES). THE INTENDED PROCEDURE WAS COMPLETED USING A TOTAL OF THREE NEEDLES. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO USER INJURY REPORTED DUE TO THE EVENT. THE ISSUE OCCURRED ON TWO NEEDLES WITH THE SAME LOT NUMBER (15V). THE TYPE OF PROCEDURE PERFORMED AT THE TIME OF THE EVENT WAS NOT PROVIDED. THIS REPORT (FIRST NEEDLE) IS RELATED TO REPORT WITH PATIENT IDENTIFIER (B)(6) ( SECOND NEEDLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622538 ↗