Single Use Aspiration Needle NA-201SX-4022 (UDI 04953170180958)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170180958), received between Oct 11, 2022 and Oct 8, 2024 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHEATH OF THE ASPIRATION NEEDLE FELL OFF AND WAS NOTICED IN THE SPECIMEN CONTAINER, BUT COULD HAVE EASILY SLIPPED INTO THE BRONCHUS. THE ISSUE OCCURRED DURING AN THERAPEUTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE COMPLETE BY USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395044 ↗
• InjuryJul 23, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, THE TIP OF A SINGLE USE ASPIRATION NEEDLE BROKE INSIDE THE PATIENT'S LYMPH NODE. THE USER WAS ABLE TO RETRIEVE THE BROKEN PIECE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM. ADDITIONAL FOLLOW-UP HAVE BEEN REQUESTED AND PENDING FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806617 ↗
• InjuryJul 23, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS EBUS (ENDOBRONCHIAL ULTRASOUND), CONDUCTED IN THE TRACHEA AND AIRWAYS JUST BEYOND THE MAIN CARINA. THE DEVICE WAS RETRIEVED WITH THE ASSISTANCE OF FORCEPS, WHICH ADDED 3-5 MINUTES TO THE PROCEDURE. HOWEVER, THE CUSTOMER NOTED THAT NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO ADVERSE EVENTS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS INCIDENT. THE PATIENT'S CURRENT CONDITION IS STABLE, WITH NO COMPLICATIONS. THE CUSTOMER IS UNSURE OF THE PROCEDURAL OUTCOME, AS EBUS IS TYPICALLY USED FOR DIAGNOSING AND STAGING LUNG CANCER, AND RESULTS ARE NOT AVAILABLE UNTIL PATHOLOGY HAS BEEN REVIEWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806578 ↗
• MalfunctionApr 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, DURING THE OPERATION IN THE AIRWAY CAVITY, THE SINGLE USE ASPIRATION NEEDLE COULD NOT BE VISUALIZED AFTER MULTIPLE PUNCTURES, AND THERE WAS RESISTANCE TO RETRACTING THE NEEDLE BACK INTO THE TUBE SHEATH; THE OPERATION WAS LATER INTERRUPTED AND THE SYRINGE WAS WITHDRAWN AND EXAMINED, AND IT WAS FOUND THAT THE NEEDLE WAS EXPOSED OUTSIDE OF THE TUBE SHEATH AND HAD BEEN BENT. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047780 ↗
• MalfunctionFeb 12, 2024Failure to Eject; Failure to Eject

  IT WAS REPORTED, THE SINGLE USE ASPIRATION NEEDLE FAILED UPON INITIAL USE. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687040 ↗
• MalfunctionFeb 12, 2024Failure to Eject; Failure to Eject

  IT WAS REPORTED, THE SINGLE USE ASPIRATION NEEDLE FAILED UPON INITIAL USE. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687003 ↗
• MalfunctionAug 17, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE ASPIRATION NEEDLE THE NEEDLE SUDDENLY BROKE, AND THE DEVICE WAS DISCARDED. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568376 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "RAPID GROWTH OF GRANULATION TISSUE: A RARE CAUSE OF STRIDOR." A 63 YO F WITH PMH OF 20 PACK YEAR TOBACCO USE PRESENTED FOR EVALUATION OF A 2.6CM X 2.4CM RUL NODULE AND MEDIASTINAL LYMPHADENOPATHY. SHE UNDERWENT NAVIGATIONAL BRONCHOSCOPY OF RUL NODULE AND EBUS-TBNA FOR MEDIASTINAL STAGING. EBUS-TBNA WAS PERFORMED USING AN OLYMPUS 21G NEEDLE AT STATIONS 11L, 4L, 7, 4R AND 11R. SHE RECOVERED POST-PROCEDURE AND DISCHARGED HOME. THE FOLLOWING EVENING, SHE DEVELOPED SHORTNESS OF BREATH AND "WHEEZING¿ WHICH PROMPTED HER TO REPORT TO ER. ON EXAM, SHE HAD AUDIBLE INSPIRATORY AND EXPIRATORY STRIDOR AND LUNGS WERE CLEAR TO AUSCULTATION BL. CXR SHOWED A SMALL RIGHT APICAL PNEUMOTHORAX WHICH RESOLVED WITH CONSERVATIVE MANAGEMENT. HOWEVER, HER STRIDOR AND SHORTNESS OF BREATH WAS UNCHANGED. THUS, REPEAT FLEXIBLE BRONCHOSCOPY WAS PERFORMED DEMONSTRATING INTERVAL DEVELOPMENT OF GRANULATION TISSUE IN THE LOWER TRACHEA AND IN THE RIGHT MAIN BRONCHUS WITH COMPLETE OBSTRUCTION OF THE RIGHT MAIN BRONCHUS. THE GRANULATION TISSUE FORMED AT THE TBNA PUNCTURE SITE AT STATIONS 7 AND 4R. ULTIMATELY, THE GRANULATION TISSUE WAS EXCISED USING CRYOTHERAPY AND SHE

  Patient problems: Dyspnea; Pneumothorax; Wheezing

  MAUDE report 15880865 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "RAPID GROWTH OF GRANULATION TISSUE: A RARE CAUSE OF STRIDOR." A 63 YO F WITH PMH OF 20 PACK YEAR TOBACCO USE PRESENTED FOR EVALUATION OF A 2.6CM X 2.4CM RUL NODULE AND MEDIASTINAL LYMPHADENOPATHY. SHE UNDERWENT NAVIGATIONAL BRONCHOSCOPY OF RUL NODULE AND EBUS-TBNA FOR MEDIASTINAL STAGING. EBUS-TBNA WAS PERFORMED USING AN OLYMPUS 21G NEEDLE AT STATIONS 11L, 4L, 7, 4R AND 11R. SHE RECOVERED POST-PROCEDURE AND DISCHARGED HOME. THE FOLLOWING EVENING, SHE DEVELOPED SHORTNESS OF BREATH AND "WHEEZING¿ WHICH PROMPTED HER TO REPORT TO ER. ON EXAM, SHE HAD AUDIBLE INSPIRATORY AND EXPIRATORY STRIDOR AND LUNGS WERE CLEAR TO AUSCULTATION BL. CXR SHOWED A SMALL RIGHT APICAL PNEUMOTHORAX WHICH RESOLVED WITH CONSERVATIVE MANAGEMENT. HOWEVER, HER STRIDOR AND SHORTNESS OF BREATH WAS UNCHANGED. THUS, REPEAT FLEXIBLE BRONCHOSCOPY WAS PERFORMED DEMONSTRATING INTERVAL DEVELOPMENT OF GRANULATION TISSUE IN THE LOWER TRACHEA AND IN THE RIGHT MAIN BRONCHUS WITH COMPLETE OBSTRUCTION OF THE RIGHT MAIN BRONCHUS. THE GRANULATION TISSUE FORMED AT THE TBNA PUNCTURE SITE AT STATIONS 7 AND 4R. ULTIMATELY, THE GRANULATION TISSUE WAS EXCISED USING CRYOTHERAPY AND SHE

  Patient problems: Dyspnea; Granuloma; Obstruction/Occlusion; Pneumothorax; Wheezing

  MAUDE report 15880717 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURE, WHEN THEY WERE HITTING LYMPH NODES THAT TIME , NEEDLE FROM DISTAL TIP BROKE AND THE EBUS SCOPE WAS WITHDRAWN. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578324 ↗