Single Use Injector NM-401L-0425 (UDI 04953170382345)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170382345), received between Mar 29, 2020 and Jul 18, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (3 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 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE INJECTOR AND SHEATHSET IS UNABLE TO INJECT MEDICATION. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE TO INJECT THE PATIENT'S MEDICATION INTO THE VOCAL CORD. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO INJECT THE MEDICATION BY DEPRESSING THE PLUNGER, RESISTANCE WAS ENCOUNTERED, AND THE PLUNGER COULD NOT BE ADVANCED TO DELIVER THE MEDICATION. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN SWITCHED TO A NEW INJECTOR AND SHEATHSET, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF ADDITIONAL MEDICAL TREATMENT OR SURGICAL INTERVENTION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772980 ↗
• 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) (1 OF 2) - NEEDLE THAT WAS NOT INJECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495617 ↗
• MalfunctionJan 25, 2023Obstruction of Flow; Obstruction of Flow

  THE OLYMPUS TERRITORY MANAGER REPORTED (ON BEHALF OF THE CUSTOMER) THAT WHILE USING THE SINGLE USE INJECTOR, FLUID WAS NOT DISPENSING THROUGH THE SYRINGE INTO THE PATIENT AS INTENDED. THE SURGEON HAD PREVIOUSLY PERFORMED THREE OTHER ATTEMPTS WITH THE SAME STYLE OF DEVICE DURING THE PROCEDURE BUT WAS UNABLE TO GET ANY FLUID THROUGH THE SYRINGES WITH THE THREE PREVIOUS DEVICES. THE SURGEON WAS SUCCESSFULLY ABLE TO INJECT THE SOLUTION USING A FOURTH SINGLE-USE INJECTOR DEVICE. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PROCEDURAL DELAY OR ADDITIONAL DEVICES ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. RELATED PATIENT IDENTIFIERS: (B)(6). (NM-401L-0425/SINGLE USE INJECTOR/SN: 29V22) AND (B)(6) (NM-401L-0425/SINGLE USE INJECTOR/SN: 29V22).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244201 ↗
• MalfunctionJan 24, 2023Obstruction of Flow; Obstruction of Flow

  THE OLYMPUS TERRITORY MANAGER REPORTED (ON BEHALF OF THE CUSTOMER) THAT WHILE USING THE SINGLE USE INJECTOR, FLUID WAS NOT DISPENSING THROUGH THE SYRINGE INTO THE PATIENT AS INTENDED. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PROCEDURAL DELAY OR ADDITIONAL DEVICES ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232122 ↗
• MalfunctionJan 23, 2023Obstruction of Flow; Obstruction of Flow

  THE OLYMPUS TERRITORY MANAGER REPORTED (ON BEHALF OF THE CUSTOMER) THAT WHILE USING THE SINGLE USE INJECTOR, FLUID WAS NOT DISPENSING THROUGH THE SYRINGE INTO THE PATIENT AS INTENDED. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PROCEDURAL DELAY OR ADDITIONAL DEVICES ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS PART OF THREE RELATED EVENTS. (PATIENT IDENTIFIERS: (B)(6) AND (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225476 ↗
• MalfunctionFeb 9, 2022No Flow; No Flow

  CUSTOMER REPORTED THAT WHEN THE NEEDLE WAS ENGAGED NO SOLUTION CAME OUT OF THE NEEDLE. THE ISSUE FOUND DURING PREPARATION FOR USE FOR A SUBGLOTTIC KENALOG INJECTIONS AND VOCAL FOLD INJECTIONS WITH BOTOX. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13492515 ↗
• MalfunctionFeb 9, 2022No Flow; No Flow

  CUSTOMER REPORTED THAT WHEN THE NEEDLE WAS ENGAGED NO SOLUTION CAME OUT OF THE NEEDLE. THE ISSUE FOUND DURING PREPARATION FOR USE FOR A SUBGLOTTIC KENALOG INJECTIONS AND VOCAL FOLD INJECTIONS WITH BOTOX. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13492303 ↗
• MalfunctionFeb 4, 2022No Flow; No Flow

  THE CUSTOMER REPORTED TO OLYMPUS THAT UPON ENGAGING THE NEEDLE NO SOLUTION CAME OUT. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORT OF DEATH, HARM, OR INJURIES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13457209 ↗
• MalfunctionDec 18, 2020Infusion or Flow Problem; Infusion or Flow Problem

  WE RECEIVED THE FOLLOWING REPORT. *THE SUBJECT DEVICE WAS USED FOR BOTOX INJECTION INTO THE BLADDER. THE CUSTOMER COULDN'T INJECT AS THERE WAS TOO MUCH RESISTANCE. THE CUSTOMER TESTED ANOTHER ONE OUTSIDE OF THE BLADDER LINING AND STILL WOULDN'T WORK. THE CUSTOMER PAUSED THE PROCEDURE. AFTER THAT, THE CUSTOMER MANAGED TO COMPLETE THE INTENDED PROCEDURE WHILE EXTENDING THE NEEDLE FROM THE TUBE (WITHOUT RETRACTING IT BACK INTO THE TUBE) SINCE THE CUSTOMER FOUND THAT ONCE EXTENDED THE NEEDLE FROM THE TUBE, COULD NOT RETRACT IT INTO THE TUBE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11034387 ↗
• MalfunctionApr 8, 2020Failure to Infuse; Failure to Infuse

  DURING DISPENSING A BOTOX IN THE BLADDER, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE NEEDLE COULD NOT INJECT BOTOX INTO THE TISSUE. IT WAS REPORTED THAT THE USER ERROR MIGHT OCCUR. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT OF THE INABILITY OF INJECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941707 ↗
• MalfunctionMar 29, 2020Failure to Infuse; Failure to Infuse

  DURING DISPENSING A BOTOX IN THE BLADDER, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE NEEDLE COULD NOT INJECT BOTOX INTO THE TISSUE. IT WAS REPORTED THAT THE USER ERROR MIGHT OCCUR. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT OF THE INABILITY OF INJECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9896220 ↗