Single Use Aspiration Needle NA-201SX-4022 (REF N5432330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04953170389887), received between Aug 2, 2018 and Apr 17, 2026 — classified as 1 death, 11 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE ASPIRATION NEEDLE WAS RETURNED SEVERED IN TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911056 ↗
• MalfunctionFeb 24, 2026No Apparent Adverse Event

  IT WAS REPORTED THE SINGLE-USE ASPIRATION NEEDLE PUNCTURED THE MANDIBLE IN THE NEEDLE. THIS OCCURRED DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429571 ↗
• MalfunctionJan 21, 2026Material Puncture/Hole; Manufacturing, Packaging or Shipping Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127905 ↗
• MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE EXHIBITED BROKE OFF. THE ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPE ENDOBRONCHIAL ULTRASOUND. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 23790149 ↗
• InjuryNov 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION UNDER SEDATION, THE PUNCTURE NEEDLE BROKE, LEAVING THE TIP LODGED IN THE SITE THAT THE USER WAS STAGING, LOWER RIGHT TRACHEAL, 4R. USING BRONCHOSCOPY, THE TIP WAS REMOVED WITH BIOPSY FORCEPS, WITHOUT FURTHER CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS PROLONGED BY AT LEAST OR GREATER THAN 30 MINUTES AND COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513642 ↗
• MalfunctionSep 17, 2025Difficult to Flush; Retraction Problem

  FROM STAFF: DOING AN EBUS [ENDOBRONCHIAL ULTRASOUND] PROCEDURE WITH DR. [REDACTED] AND EBUS NEEDLE WAS HARD TO FLUSH SPECIMEN OUT OF AND UNABLE TO THREAD STYLET BACK INTO EBUS NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072427 ↗
• MalfunctionSep 2, 2025Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED THAT TWO NEEDLES WERE BENT. ADDITIONALLY, PRESSURE WAS NOTED WHEN PASSING THE NEEDLE INSIDE THE WORKING CHANNEL, RESULTING IN THE CHANNEL BEING PRICKED. THE REPORTED ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS), WHICH WAS COMPLETED USING ANOTHER DEVICE. THE CUSTOMER RETURNED FIVE (5) NEEDLES (SAME MODEL NUMBER, DIFFERENT LOT) RELATED TO THIS EVENT. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 3 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947036 ↗
• MalfunctionSep 2, 2025Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED THAT TWO NEEDLES WERE BENT. ADDITIONALLY, PRESSURE WAS NOTED WHEN PASSING THE NEEDLE INSIDE THE WORKING CHANNEL, RESULTING IN THE CHANNEL BEING PRICKED. THE REPORTED ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS), WHICH WAS COMPLETED USING ANOTHER DEVICE. THE CUSTOMER RETURNED FIVE (5) NEEDLES (SAME MODEL NUMBER, DIFFERENT LOT) RELATED TO THIS EVENT. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 5 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946628 ↗
• MalfunctionSep 2, 2025Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED THAT TWO NEEDLES WERE BENT. ADDITIONALLY, PRESSURE WAS NOTED WHEN PASSING THE NEEDLE INSIDE THE WORKING CHANNEL, RESULTING IN THE CHANNEL BEING PRICKED. THE REPORTED ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS), WHICH WAS COMPLETED USING ANOTHER DEVICE. THE CUSTOMER RETURNED FIVE (5) NEEDLES (SAME MODEL NUMBER, DIFFERENT LOT) RELATED TO THIS EVENT. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 4 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946133 ↗
• MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A DIAGNOSTIC EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE, THE NEEDLE WAS WORKING FINE (HAD BEEN USED ON A LYMPH NODE STATION BEFORE) AND WHEN THE PHYSICIAN WAS FINISHING UP ON A NODE, HE PULLED BACK ON THE NEEDLE TO LOCK IT BEFORE REMOVING FROM THE WORKING CHANNEL AND THE WHOLE PLASTIC TOP OF NEEDLE SEPARATED FROM THE BOTTOM BY THE SHEATH ADJUSTER. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882487 ↗
• InjuryJun 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE FOR A DIAGNOSTIC TRANSBRONCHIAL BIOPSY USING A SINGLE-USE ASPIRATION NEEDLE, THE SHEATH OF THE NEEDLE BROKE OFF AND BECAME LODGED IN THE RIGHT MAIN BRONCHUS DURING THE SECOND PUNCTURE AS THE NEEDLE WAS BEING WITHDRAWN. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY FIVE MINUTES DUE TO THE REPLACEMENT OF THE EBUS DEVICE WITH A REGULAR BRONCHO FIBERSCOPE AND THE SUBSEQUENT REMOVAL OF THE ELEMENT FROM THE BRONCHUS. THE SHEATH WAS REMOVED WITH FORCEPS, AND THE BRONCHIAL TREE WAS EXAMINED, WITH NO OTHER FOREIGN BODIES FOUND. DUE TO THE SITUATION, THE SINGLE USE ASPIRATION NEEDLE WAS NOT USED FURTHER AND THE PROCEDURE WAS COMPLETED WITH USE OF A SIMILAR DEVICE. IN ADDITION, THE SINGLE USE ASPIRATION NEEDLE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES OBSERVED, AND THE MANDREL THAT SECURES THE SINGLE USE ASPIRATION NEEDLE WAS ALSO EXAMINED, WITH NO ABNORMALITIES OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY OR HARM AS A RESULT OF THE DEVICE ISSUE. THE PATIENT'S CURRENT HEALTH STATUS WAS DESCRIBED AS SIGNIFICANTLY DEBILITATED, WITH EXERTIONAL DYSPNEA; HOWEVER, THERE IS CURRENTLY NO EVIDENCE TO SUGGEST THAT THIS CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347793 ↗
• MalfunctionJun 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A DIAGNOSTIC NEEDLE BIOPSY PROCEDURE, THE SUBJECT DEVICE WAS UNABLE TO ATTACH TO THE CONNECTION SLIDE OF THE SINGLE-USE VALVE. THE SLIDE DID NOT LOCK, AND THE NEEDLE PIERCED THE ECHO ENDOSCOPE SHEATH. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284263 ↗
• MalfunctionJun 13, 2025Contamination; Material Erosion; Contamination; Material Erosion

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE HAD A BLACK ABRASION MARK ON THE COMPRESS DUE TO A LEAKAGE OF SALINE SOLUTION. THE ISSUE OCCURRED DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205574 ↗
• MalfunctionJun 13, 2025Contamination; Material Erosion; Contamination; Material Erosion

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE HAD A BLACK ABRASION MARK ON THE COMPRESS DUE TO A LEAKAGE OF SALINE SOLUTION. THE ISSUE OCCURRED DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205551 ↗
• MalfunctionJun 13, 2025Contamination; Material Erosion; Contamination; Material Erosion

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE HAD A BLACK ABRASION MARK ON THE COMPRESS DUE TO A LEAKAGE OF SALINE SOLUTION. THE ISSUE OCCURRED DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205507 ↗
• InjuryJun 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC ENDOSCOPIC BRONCHIAL ULTRASOUND (EBUS), THE TIP PF THE SUBJECT DEVICE BROKE OFF INSIDE THE PATIENT. THE CLINICIAN WAS ASPIRATING FLUID FROM THE PATIENT FOR CYTOLOGY. THE SUBJECT DEVICE WAS WITHDRAWN AFTER ONE SUCCESSFUL PASS. WHEN THE CLINICIAN ATTEMPTED TO INSERT THE NEEDLE AGAIN, IT WOULDN'T GO ALL THE WAY IN. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. DURING THE FINAL INSPECTION OF THE PROCEDURE, THE CLINICIAN VISUALLY EXAMINED THE AREA INSIDE THE PATIENT AND SAW A SHINY OBJECT. THE BROKEN PIECE WAS EXTRACTED WITH FORCEPS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191153 ↗
• InjuryJun 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE AN UPDATE TO THE FOLLOWING FIELDS:D3, D4, D9, F9 AND F14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191152 ↗
• MalfunctionJun 2, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO A BRONCHOSCOPY PROCEDURE, THE SUBJECT DEVICE WAS INSPECTED AFTER BEING TAKEN OUT OF THE BOX, AND THE DOCTOR NOTICED THE LOCK WAS STUCK AND THE NEEDLE WAS NOT ABLE TO BE DEPLOYED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128555 ↗
• MalfunctionMay 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034663 ↗
• MalfunctionMay 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018356 ↗
• MalfunctionMay 2, 2025Material Puncture/Hole; Deformation Due to Compressive Stress; Material Twisted/Bent; Material Puncture/Hole; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DIAGNOSTIC PUNCTURE PROCEDURE, THE CATHETER OF THE NEEDLE WAS KINKED, AND THE NEEDLE DAMAGED THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954641 ↗
• InjuryMar 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SINGLE-USE ASPIRATION NEEDLE BROKE INSIDE THE PATIENT, LEAVING A PIECE OF APPROXIMATELY 3 CM LODGED IN THE LEFT MAIN BRONCHUS, WHICH WAS RECOVERED USING A CLAMP. THERE WAS A PROCEDURAL DELAY OF LESS THAN 30 MINUTES WHILE THE PATIENT WAS SEDATED. A BACKUP DEVICE WAS USED TO COMPLETE THE DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646576 ↗
• MalfunctionMar 17, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE WENT OUT OF ADJUSTMENT DURING THE FIRST PUNCTURE, EVEN THOUGH IT HAD BEEN ADJUSTED BEFOREHAND. THIS LED TO THE OPERATOR CHANNEL OF THE ECHO-ENDOSCOPE BEING PIERCED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21625482 ↗
• MalfunctionMar 13, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595712 ↗
• InjuryJan 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BRONCHIAL PUNCTURE PROCEDURE, THE SINGLE USE ASPIRATION NEEDLE BROKE OFF IN THE PATIENT¿S LUNG. THE DEVICE WAS CHANGED TO USE A BRONCHOSCOPE WITH AN OPERATIONAL CHANNEL AND THE NEEDLE WAS RETRIEVED WITH A BRONCHIAL BIOPSY FORCEPS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057636 ↗