Single Use Aspiration Needle NA-U401SX NA-U401SX-4022 (UDI 04953170388286)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04953170388286), received between May 25, 2018 and Aug 19, 2026 — classified as 3 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K160098); they may or may not involve this specific model.

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.

Recalls naming this device

1. Mar 31, 2023Class IIIOpen, Classified

   Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.

   Z-1616-2023 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Device Damaged by Another Device; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324955 ↗
• MalfunctionApr 28, 2026Material Twisted/Bent

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE ASPIRATION NEEDLE'S SHEATH WAS BUCKLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018964 ↗
• MalfunctionApr 17, 2026Fracture

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE ASPIRATION NEEDLE'S INSERTION PORTION WAS SEVERED APPROXIMATELY 3 CM UNDER THE BOOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910743 ↗
• MalfunctionFeb 24, 2026Packaging Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430419 ↗
• MalfunctionFeb 24, 2026Packaging Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430311 ↗
• MalfunctionFeb 24, 2026Packaging Problem

  IT WAS REPORTED THE ASPIRATION NEEDLE HAD PUNCTURED THE PACKAGING SEAL. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429992 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THE SINGLE-USE ASPIRATION NEEDLE APPEARED TO HAVE "ERODED" AROUND THE DISTAL TIP OF THE GREEN CATHETER AFTER "A COUPLE OF PASSES". THIS WAS NOTED DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DEVICE OF A DIFFERENT MAKE/MANUFACTURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037580 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE ASPIRATION NEEDLE, SHEATH WAS BUCKLING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598601 ↗
• InjuryMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE METAL SHEATH OF THE SINGLE USE ASPIRATION NEEDLE CAME LOOSE AND FELL INTO THE PATIENT. THE FALLEN PIECE WAS RETRIEVED FROM THE PATIENT WITHOUT ANY COMPLICATIONS. THERE WAS A PROCEDURAL DELAY OF LESS THAN 30 MINUTES, AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105374 ↗
• MalfunctionMay 20, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE LOST CONTROL OF ITS FORWARD AND BACKWARD MOVEMENT. THE ISSUE OCCURRED BEFORE MEDIASTINAL TUMOR BIOPSY/BRONCHOSCOPY WITH TRANSBRONCHIAL BIOPSY BEFORE THE PATIENT WAS UNDER SEDATION. THERE WAS A DELAY OF AN UNKNOWN TIME PERIOD. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 22056133 ↗
• MalfunctionNov 6, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE'S STYLET COULD NOT BE INSERTED. THE ISSUE OCCURRED DURING EBUS-TBNA (ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622545 ↗
• InjuryFeb 2, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY THE NEEDLE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE IT USING AN ADULT BRONCHOSCOPE AND BIOPSY FORCEPS, AVOIDING INJURY WHILE DOING SO. THE PROCEDURE WAS COMPLETED BUT NOT WITH THE SAME DEVICE. THE DEVICE ISSUE DID NOT IMPACT THE OUTCOME OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636724 ↗
• MalfunctionOct 16, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE ASPIRATION NEEDLE¿S TIP WAS BROKEN OFF. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17941706 ↗
• MalfunctionOct 13, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE ASPIRATION NEEDLE¿S TIP WAS BROKEN OFF. THERE WERE NO REPORTS OF PATIENT HARM. ASSOCIATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936304 ↗
• MalfunctionOct 13, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE ASPIRATION NEEDLE¿S TIP WAS BROKEN OFF. THERE WERE NO REPORTS OF PATIENT HARM. ASSOCIATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936302 ↗
• MalfunctionOct 5, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE ASPIRATION NEEDLE TIP BROKE OFF. THERE WERE NO REPORTS OF PATIENT HARM. ASSOCIATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17874327 ↗
• MalfunctionSep 21, 2023Break; Break

  THE CUSTOMER REPORTED THE SINGLE USE ASPIRATION NEEDLE BROKE OFF IN THE HANDLE DURING THE PROCEDURE. THE NEEDLE COULD NOT BE REMOVED WITHOUT HARMING THE PATIENT OR SCOPE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17792308 ↗
• MalfunctionAug 15, 2023Component Missing; Tear, Rip or Hole in Device Packaging; Component Missing; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE ASPIRATION NEEDLE WAS MISSING FROM THE ITEM¿S PACKAGE DUE TO A HOLE, OR IRREGULARITY FOUND IN THE SEALED STERILE PACKAGE. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553632 ↗
• MalfunctionFeb 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AN OLYMPUS EMPLOYEE REPORTED THAT, WHEN SETTING UP FOR A CASE, THE CUSTOMER PICKED UP HER DEMONSTRATION DEVICE AND USED IT DURING THE UNSPECIFIED DIAGNOSTIC PROCEDURE. THE CUSTOMER ASKED THE EMPLOYEE TO COME INTO THE FACILITY TO SUPPORT A PROCEDURE AS IT HAD BEEN A WHILE SINCE THEY PERFORMED THIS PROCEDURE. WHEN SHE ARRIVED, SHE BROUGHT IN HER DEMONSTRATION 22G NEEDLE THAT WAS OPENED AND HAD BEEN USED IN A DEMONSTRATION PREVIOUSLY AND TOUCHED BY MULTIPLE PEOPLE. THE SURGICAL ROOM WAS NOT PREPARED AND SHE WAS ASKED TO HELP SET UP THE INSTRUMENTS. SHE SET DOWN HER DEMONSTRATION NEEDLE IN AN AREA OUTSIDE THE STERILE AREA IN THE SURGICAL ROOM. THE CUSTOMER REQUESTED HER HELP TO TRACK DOWN INSTRUMENTS NEEDED IN THE PROCEDURE. WHEN SHE RETURNED SHE WAS TOLD THAT THE DOCTOR WANTED A 19G NEEDLE BUT ONE COULD NOT BE LOCATED. WHEN THE EMPLOYEE CAME BACK FROM LOOKING FOR A 19G NEEDLE, THE DOCTOR WAS USING A NEEDLE IN THE CASE. IT WAS NOT UNTIL LATER THAT SHE REALIZED HER DEMONSTRATION NEEDLE WAS NOT WHERE SHE LEFT IT AND HAD BEEN USED BY THE DOCTOR IN THE PROCEDURE. SHE INFORMED THE DOCTOR THAT THE NEEDLE WAS OPENED AND USED IN OTHER DEMONSTRATIONS AND THAT OTHER DOCTORS HAD TOUCHED THE DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312845 ↗
• MalfunctionFeb 26, 2022Mechanical Problem; Mechanical Problem

  AS REPORTED, CUSTOMER REPORTED OF "DIFFICULTY IN FIXATION OF THE NEEDLE" (IT MOVES EASILY EVEN WITH THE MAXIMUM FIXATION). VERY DIFFICULT TO PENETRATE THE TRACHEAL WALL, LYMPH NODE STRUCTURE AND IN THE BACK AND FORTH MOVEMENTS. DEFORMATION OF THE NEEDLE WITH THE USE. VERY POOR ULTRASOUND VISUALIZATION. THE EVENT OCCURRED DURING A PROCEDURE (ULTRASOUND GUIDED PUNCTURE). NO PATIENT DAMAGED. NO EXTENSION OF THE PROCEDURE AS A RESULT OF THE EVENT. 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 13611190 ↗
• InjuryJan 19, 2022Break; Difficult to Advance; Break; Difficult to Advance

  THE CUSTOMER REPORTED TO OLYMPUS, THE SUBJECT DEVICE BROKE DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL NEEDLE ASPIRATION. THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE NEEDLE INTO A LYMPH NODE. THEN, THE SHEATH WAS RETRACTED INTO THE BRONCHOSCOPE AND THE STAFF NOTICED THE TIP OF THE NEEDLE WAS MISSING. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. ANOTHER BRONCHOSCOPY AND X-DAY DID NOT REVEAL THE NEEDED TIP INSIDE OF THE PATIENT. THE PATIENT DID NOT HAVE AN EXTENDED HOSPITAL STAY PER THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13288861 ↗
• MalfunctionJul 15, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY A CLINICAL STAFF THAT DURING A PROCEDURE OF AN ENDOSCOPIC BRONCHIAL ULTRASOUND USING THE SUBJECT DEVICE AS FOLLOWS. ¿WE HAVE AN EBUS NEEDLE THAT DURING A PROCEDURE COULD NOT RETRACT AND WHEN IT WAS RETRACTED THE NEEDLE HAD BROKEN OFF. NEEDLE FAILED TO RETRACT DURING PROCEDURE, NEEDLE REMOVED FROM PATIENT AND SCOPE AND FOUND PIECE OF NEEDLE MISSING DURING A BRONCH PROCEDURE THE PATIENT GETS SPRAYED WITH NOVOCAINE SPRAY TO NUMB THE VOCAL CORDS AND USUALLY HAVE NO FEELING IS SURROUNDING AREA. COUGHING IS MOSTLY A REFLEX REACTION. THEY WERE LOOKING FOR THE NEEDLE IN THE LUNGS WITH A SCOPE, WHEN THEY RETRIEVED THE SCOPE SHE COUGHED AND THEN SWALLOWED. THEY ASSUME THAT¿S WHEN SHE SWALLOWED IT. SHE WAS THEN SENT TO CT AND A GASTROSCOPY, THEY DID NOT FIND IT IN THE STOMACH. THE PATIENT UNDERWENT A CT SCAN ON SATURDAY MORNING AT THAT STAGE THE NEEDLE TEST WAS IN THE SIGMOID.¿ ALSO, IT WAS INFORMED BY A NURSE AS FOLLOWS. ¿WEDNESDAY 23 JUNE - NEEDLE BROKE OFF IN PATIENT. THURSDAY 24 JUNE - OLYMPUS REPRESENTATIVE COLLECTED DEFECTIVE PRODUCT (WE WERE TOLD AT THE TIME THAT THE PATIENT WAS ADMITTED AND UNDER OBSERVATION IN HDU). GASTROSCOPY WAS

  Patient problems: Cough; Foreign Body In Patient

  MAUDE report 12178866 ↗
• MalfunctionJan 27, 2021Mechanical Problem; Mechanical Problem

  IT IS REPORTED A SINGLE USE ASPIRATION NEEDLE WOULD NOT LOCK. THE SHEATH WOULD NOT STAY LOCKED AND THE NEEDLE CAME OUT PUNCTURING THE INSERTION TUBE OF THE SCOPE. THERE WAS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11237410 ↗
• MalfunctionJan 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE SERVICE CENT WAS INFORMED THAT DURING A PROCEDURE, WHILE EXPELLING THE SPECIMEN FROM THE TIP OF THE NEEDLE THE CUSTOMER EXPERIENCED DIFFICULTY AND THE PATHOLOGIST WAS SPRAYED TWICE. THE CUSTOMER FURTHER INVESTIGATED THE NEEDLE AND NOTICED THE SPRAY WAS COMING FROM THE GREEN COVERING THAT MEETS THE COIL SHEATH AT THE CONNECTOR. THE REPORTED THAT WHEN EXPELLING THE SPECIMEN THE NEEDLE WAS NOT EXTEND OUT OF THE SHEATH, WHICH MAY HAVE CAUSED THE PROBLEM DUE TO THE FACT THE SPECIMEN WAS VERY LARGE AND CLOGGED THE TIP. THE CUSTOMER BELIEVES THIS MAY HAVE BEEN THE REASON FOR SPECIMEN BACKING UP IN THE SHEATH. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT/USER INJURY OR INFECTION REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 11118010 ↗
• MalfunctionDec 6, 2019Break; Break

  DURING AN ENDOBRONCHIAL ULTRASONOGRAPHY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE USER FOUND THAT THE TUBE SHEATH WAS BROKEN. AND THE USER COULD NOT RETRACT THE NEEDLE INTO THE TUBE SHEATH. THE USER COULD NOT TAKE OUT THE SUBJECT DEVICE FROM THE ENDOSCOPE. THE USER TOOK OUT THE ENDOSCOPE FROM THE PATIENT WHILE THE SUBJECT DEVICE WITH THE EXTENDED NEEDLE LEFT IN THE ENDOSCOPE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE REPORT REGARDING THE INABILITY TO RETRACT THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9421324 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160098. One submission often covers many models, so check the product and lot details in each record.

• Z-1615-2023 · Mar 31, 2023 · Open, Classified
  ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the t