Single Use Injector NM-401L-0523 (REF N6140430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170422645), received between Sep 28, 2021 and Dec 2, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 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.

• MalfunctionDec 2, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR MALFUNCTIONED DURING THE INJECTION OF BOTOX INTO THE VOCAL FOLDS. THE SYRINGE PLUNGER WAS REPORTED TO HAVE BEEN FORCED BACK. THE DOCTOR ASKED THE STAFF TO REATTACH THE SYRINGE TO THE INJECTOR TO ATTEMPT THE INJECTION A SECOND TIME. AGAIN, THE SYRINGE WAS FULLY PRESSED, APPEARING TO DELIVER THE MEDICATION, BUT THE SYRINGE PLUNGER BOUNCED BACK WHEN THE USER'S THUMB WAS REMOVED FROM PLUNGER. THERE WERE NO REPORTS PATIENT HARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23698041 ↗
• MalfunctionFeb 17, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE FLUID WOULD NOT FLOW THROUGH THE SINGLE-USE INJECTOR NEEDLE WHEN ADVANCED OUTSIDE OF THE SHEATH. WHEN RETRACTED INTO THE SHEATH, FLUID FLOWED THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT DEATH, HARM, OR INJURIES. THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552142 ↗
• MalfunctionFeb 17, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE FLUID WOULD NOT FLOW THROUGH THE SINGLE-USE INJECTOR NEEDLE WHEN ADVANCED OUTSIDE OF THE SHEATH. WHEN RETRACTED INTO THE SHEATH, FLUID FLOWED THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT DEATH, HARM, OR INJURIES. THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED EVENTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552104 ↗
• MalfunctionFeb 17, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE FLUID WOULD NOT FLOW THROUGH THE SINGLE-USE INJECTOR NEEDLE WHEN ADVANCED OUTSIDE OF THE SHEATH. WHEN RETRACTED INTO THE SHEATH, FLUID FLOWED THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT DEATH, HARM, OR INJURIES. THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552008 ↗
• MalfunctionFeb 17, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE FLUID WOULD NOT FLOW THROUGH THE SINGLE-USE INJECTOR NEEDLE WHEN ADVANCED OUTSIDE OF THE SHEATH. WHEN RETRACTED INTO THE SHEATH, FLUID FLOWED THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT DEATH, HARM, OR INJURIES. THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551912 ↗
• MalfunctionFeb 17, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE FLUID WOULD NOT FLOW THROUGH THE SINGLE-USE INJECTOR NEEDLE WHEN ADVANCED OUTSIDE OF THE SHEATH. WHEN RETRACTED INTO THE SHEATH, FLUID FLOWED THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT DEATH, HARM, OR INJURIES. THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551189 ↗
• MalfunctionSep 28, 2021Failure to Fire; Failure to Fire

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE OLEATE OR SERUM WOULD NOT COME OUT THROUGH THE NEEDLE LUMEN WITH THE NEEDLE OUT. THE LIQUID WAS COMING OUT WITH THE NEEDLE SHEATHED. THIS DEVICE IS USED TO INJECT ETHANOLAMINE OLEATE BY INTRA-MUCOSAL BRONCHIAL PUNCTURE, WITH THE INTENTION OF CLOSING SMALL BRONCHOPLEURAL FISTULAS. IT WAS NOT POSSIBLE TO USE THE DEVICE. TWO OTHER DEVICES FROM DIFFERENT BOXES WERE TRIED AND HAD THE SAME ISSUE. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540522 ↗
• MalfunctionSep 28, 2021Failure to Fire; Failure to Fire

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE OLEATE OR SERUM WOULD NOT COME OUT THROUGH THE NEEDLE LUMEN WITH THE NEEDLE OUT. THE LIQUID WAS COMING OUT WITH THE NEEDLE SHEATHED. THIS DEVICE IS USED TO INJECT ETHANOLAMINE OLEATE BY INTRA-MUCOSAL BRONCHIAL PUNCTURE, WITH THE INTENTION OF CLOSING SMALL BRONCHOPLEURAL FISTULAS. IT WAS NOT POSSIBLE TO USE THE DEVICE. TWO OTHER DEVICES FROM DIFFERENT BOXES WERE TRIED AND HAD THE SAME ISSUE. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540511 ↗
• MalfunctionSep 28, 2021Failure to Fire; Failure to Fire

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE OLEATE OR SERUM WOULD NOT COME OUT THROUGH THE NEEDLE LUMEN WITH THE NEEDLE OUT. THE LIQUID WAS COMING OUT WITH THE NEEDLE SHEATHED. THIS DEVICE IS USED TO INJECT ETHANOLAMINE OLEATE BY INTRA-MUCOSAL BRONCHIAL PUNCTURE, WITH THE INTENTION OF CLOSING SMALL BRONCHOPLEURAL FISTULAS. IT WAS NOT POSSIBLE TO USE THE DEVICE. TWO OTHER DEVICES FROM DIFFERENT BOXES WERE TRIED AND HAD THE SAME ISSUE. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540493 ↗