Single Use Aspiration Needle NA-201SX-4022 (REF N5432530)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04953170389900), received between Oct 1, 2020 and Oct 23, 2025 — classified as 6 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THE WHEN THE USER WAS WITHDRAWING THE SUBJECT DEVICE AFTER THE PUNCTURE STEP WAS OVER, THE ADJUSTER LOCK WAS FRACTURED, RESULTING IN THE WITHDRAWAL OF THE SUBJECT DEVICE WHICH WAS NOT SMOOTH. THE ISSUE OCCURRED DURING A SUBCARINAL LYMPH NODE PUNCTURE VIA ULTRASOUND BRONCHOSCOPY TO OBTAIN PATHOLOGICAL SPECIMENS AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372475 ↗
• InjuryOct 7, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE BURST AFTER INSERTING IT INTO THE BRONCHI AND WHILE TRYING TO COLLECT THE BIOPSY DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY PROCEDURE. THE DROPPED NEEDLE FRAGMENT WAS RECOVERED USING ENDOSCOPY TOOLS. THE PROCEDURE WAS PROLONGED ABOUT 10 TO 15 MINUTES AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385680 ↗
• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THE ASPIRATION NEEDLE WAS BROKEN. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THE PATIENT HAD NOT RECEIVED ANESTHESIA. THE UNSPECIFIED PROCEDURE WAS FINISHED USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19303551 ↗
• MalfunctionApr 26, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE DESPITE HAVING TIGHTENED THE SAMPLING SAFETY DEVICE (GREY SCREW), THERE WAS NO LOCKING OF THE PUNCTURE DEPTH AND THEREFORE NO SAFETY DEVICE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY PROCEDURE AND 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 19193394 ↗
• MalfunctionApr 26, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE DESPITE HAVING TIGHTENED THE SAMPLING SAFETY DEVICE (GREY SCREW), THERE WAS NO LOCKING OF THE PUNCTURE DEPTH AND THEREFORE NO SAFETY DEVICE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY PROCEDURE AND 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 19190140 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORPORATON RECEIVED A LITERATURE TITLED "EFFICACY OF ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION IN THE DIAGNOSIS OF MEDIASTINAL AND HILAR LESIONS". THIS STUDY AIMED TO INVESTIGATE THE CLINICAL EFFICACY OF EBUS-TBNA IN THE DIAGNOSIS AND DIFFERENTIAL DIAGNOSIS OF MEDIASTINAL AND HILAR LESIONS. A RETROSPECTIVE OBSERVATIONAL STUDY WAS UNDERTAKEN TO INVESTIGATE PATIENTS DIAGNOSED WITH MEDIASTINAL AND HILAR LYMPHADENOPATHY BASED ON IMAGING AT OUR HOSPITAL FROM 2020 TO 2021. AFTER EVALUATION, EBUS TBNA WAS USED AND DATA INCLUDING THE PUNCTURE SITE, POSTOPERATIVE PATHOLOGY, AND COMPLICATIONS WERE RECORDED. DATA FROM 137 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 135 UNDERWENT SUCCESSFUL EBUS TBNA. A TOTAL OF 149 LYMPH NODE PUNCTURES WERE PERFORMED, OF WHICH 90 PUNCTURES IDENTIFIED MALIGNANT LESIONS. THE MOST COMMON MALIGNANCIES WERE SMALL-CELL LUNG CARCINOMA, ADENOCARCINOMA, AND SQUAMOUS CELL CARCINOMA. FORTY-ONE BENIGN LESIONS WERE IDENTIFIED, RESULTING FROM SARCOIDOSIS, TUBERCULOSIS, AND REACTIVE LYMPHADENITIS, AMONGST OTHERS. FOLLOW-UP FINDINGS SHOWED THAT 4 CASES WERE MALIGNANT TUMORS, WITH 1 CASE OF PULMONARY TUBERCULOSIS AND 1 CASE OF

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18624599 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ASPIRATION NEEDLE BROKE AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614628 ↗
• InjuryNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT AFTER USING A SINGLE USE ASPIRATION NEEDLE IN THE LUNG, THE TIP WAS MISSING UPON REMOVAL. IT REMAINED IN THE PATIENT'S LUNG AS THE NEEDLE HAD BROKEN. ADDITIONAL INFORMATION ABOUT THE PROCEDURE, RETRIEVAL OF THE NEEDLE TIP AND OUTCOME WERE REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158635 ↗
• InjurySep 25, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER INITIALLY REPORTED THAT A PIECE OF THE BIOPSY VALVE BROKE AND FELL INTO THE BODY. ADDITIONAL INFORMATION WAS LATER RECEIVED CLARIFYING THAT THE BROKEN TIP OF THE SINGLE USE ASPIRATION NEEDLE FELL INSIDE THE PATIENT'S BRONCHUS DURING AN UNSPECIFIED PROCEDURE. AFTER THE PATIENT'S VITAL SIGNS WERE STABLE, A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND THE TIP WAS FOUND. THE EXPERTS IN THE HOSPITAL WERE IMMEDIATELY CONSULTED, AND IT WAS UNANIMOUSLY BELIEVED THAT THE RISK OF REMOVAL WAS HIGH, WHICH COULD LEAD TO SEVERE HEMOPTYSIS AND ASPHYXIA. THE PATIENT WAS TRANSFERRED TO A HIGHER-LEVEL HOSPITAL FOR TREATMENT. THE PATIENT'S VITAL SIGNS WERE STABLE, AND THE BROKEN TIP WAS REMOVED. IT WAS NOT KNOWN HOW IT WAS REMOVED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND THERE WAS NO FURTHER PATIENT IMPACT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17808976 ↗
• MalfunctionJul 21, 2023Material Perforation; Mechanical Jam; Material Perforation; Mechanical Jam

  IT WAS REPORTED TO OLYMPUS, THAT THE SINGLE USE ASPIRATION NEEDLE ENCOUNTERED RESISTANCE WHEN IT WAS INSERTED FOR AN ENDOBRONCHIAL ULTRASOUND GUIDED BIOPSY AND THE NEEDLE WAS WITHDRAWN FROM THE SHEATH. THE NEEDLE WAS REMOVED FROM THE DEVICE AND RECHECKED. THE PROCEDURE WAS ATTEMPTED AGAIN AND THE NEEDLE WAS AGAIN WAVED FROM THE SHEATH. THE NEEDLE SHEATH WAS FOUND TO BE PUNCTURED LATERALLY ABOUT 0.5 CM FROM THE END. THE NEEDLE PIERCED THE SHEATH ON THE SIDE WHICH WAS VISIBLE. THE BIOPSY WAS FOR THE EVALUATION OF NODAL LESIONS (HILAR LYMPHADENOPATHY) AND IT WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS CONNECTED TO A LEAK TESTED AND THE LEAK TEST SHOWED THAT THE ULTRASOUND BRONCHOFIBEROSCOPE WAS DAMAGED AND LEAKING FROM THE BIOPSY CHANNEL. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373557 ↗
• MalfunctionJun 26, 2023Positioning Problem; Positioning Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE ASPIRATION NEEDLE ADJUSTER COULD NOT BE LOCKED DURING THE PUNCTURE PROCESS, THUS THE PUNCTURE SITE COULD NOT BE FIXED. THE ISSUE WAS FOUND DURING A DIAGNOSTIC PULMONARY LYMPH NODE PUNCTURE BIOPSY, THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE, AND WITHOUT DELAY. THE PATIENT WAS UNDER GENERAL ANESTHESIA, AND THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204856 ↗
• MalfunctionJun 19, 2023Break; Break

  THE CUSTOMER REPORTED THE SINGLE USE ASPIRATION NEEDLE WAS DAMAGED AFTER IT WAS REMOVED FROM THE SCOPE. THE EVENT OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND OPERATION. A SIMILAR DEVICE WAS USED TO COMPLETE THE OPERATION AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153881 ↗
• MalfunctionJun 5, 2023Material Puncture/Hole; Material Puncture/Hole

  AN OLYMPUS ON-SITE SERVICE TECHNICIAN REPORTED ON BEHALF OF A CUSTOMER, A SINGLE USE ASPIRATION NEEDLE WAS INSERTED INTO A BF-UC190F (EVIS EUS ULTRASOUND BRONCHOFIBERSVIDEOSCOPE) TO PERFORM AN ENDOBRONCHIAL ULTRASOUND (EBUS) BIOPSY. THE BIOPSY WAS DIFFICULT DUE TO ANATOMICAL CONDITIONS AND INVOLVED THE NEED TO BEND THE PROBE OF THE ENDOSCOPE AS MUCH AS POSSIBLE. ONCE THE NEEDLE WAS INSERTED INTO THE EBUS CANAL, IT LOCKED PROPERLY. WHEN ATTEMPTING TO PERFORM THE BIOPSY, THERE WAS RESISTANCE, AND THE NEEDLE WAS NOT ABLE TO SLIDE OUT OF THE SHEATH. THE NEEDLE WAS REMOVED FROM THE ULTRASOUND BRONCHOFIBERSCOPE AND CHECKED, THERE WAS A LATERAL PUNCTURE OF THE NEEDLE SHEATH ABOUT 0.5 CENTIMETER FROM THE END. INSTEAD OF THE NEEDLE EXTENDING CENTRALLY, IT PIERCED THE SHEATH FROM THE SIDE. WHEN CHECKING THE NEEDLE OUTSIDE THE SCOPE, IT SLIPPED OUT OF THE SHEATH WITHOUT ANY ISSUES DESPITE THE LATERAL PUNCTURE OF THE SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061605 ↗
• MalfunctionApr 28, 2023Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  THE CUSTOMER REPORTED EVENT OCCURRED PRIOR TO A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE (VIZISHOT 2). ADDITIONALLY, THE CUSTOMER REPORTED THAT THE EVENT DID NOT IMPACT THE OUTCOME OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831603 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "DIAGNOSTIC YIELD AND SAFETY OF CP-EBUS-TBNA AND RP-EBUS-TBLB UNDER MODERATE SEDATION: A SINGLE-CENTER RETROSPECTIVE AUDIT". THIS RETROSPECTIVE REVIEW STUDY AIMED TO DESCRIBE THE DIAGNOSTIC YIELD AND SAFETY OF CP-EBUS-TBNAS AND RP-EBUS-TBLBS WHEN PERFORMED UNDER MODERATE SEDATION IN 421 PATIENTS. THE DIAGNOSTIC YIELD OF THE CP-EBUS-TBNAS AND RP-EBUS-TBLBS WERE 62.5% AND 71.6%, RESPECTIVELY. THE MOST FREQUENT DIAGNOSIS FOR CP-EBUS-TBNAS WERE MALIGNANCY, SARCOIDOSIS, AND MYCOBACTERIUM INFECTION (50.9%, 6.3%, AND 4.2%, RESPECTIVELY). THE MOST FREQUENT DIAGNOSES FOR RP-EBUS - TBLBS WERE MALIGNANCY, ORGANIZING PNEUMONIA, AND MYCOBACTERIUM INFECTION (45.8%, 10% AND 3.7%, RESPECTIVELY) THIS STUDY CONCLUDES THAT PERFORMING CP-EBUS-TBNAS AND RP-EBUS-TBLBS UNDER MODERATE SEDATION IS SAFE AND PROVIDES GOOD DIAGNOSTIC YIELD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: BLEEDING - 50 PATIENTS. PNEUMOTHORAX - 1 PATIENT. HYPOXIA - 2 PATIENTS. RESPIRATORY COMPLAINTS OR FEVER - 10 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 6 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6)/NA-201SX-4022. (B)(6)/BF-UC260FW. (B)(6)/FB-231D

  Patient problems: Fever; Hemorrhage/Blood Loss/Bleeding; Hypoxia; Pneumothorax; Unspecified Respiratory Problem

  MAUDE report 16163842 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED THE NEEDLE STYLET BROKE OFF AFTER THE FIRST NEEDLE PASS. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER NEEDLE AND THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED. CUSTOMER REPORTED NO IMPACT ON THE PROCEDURE AS THE RESULT OF THE EVENT. THERE WAS NO PATIENT HARM, NO ADVERSE EVENT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578528 ↗
• MalfunctionJun 8, 2022Device Fell; Device Fell

  AS REPORTED, THE STOPPER FLEW OFF WHEN THE PATIENT COUGHED. THE INTENDED PROCEDURE WAS A DIAGNOSTIC PROCEDURE. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED , NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634766 ↗
• InjuryJun 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON MAY 31, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "LEARNING ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL NEEDLE ASPIRATION - A 6-YEAR EXPERIENCE AT A SINGLE INSTITUTION". THIS STUDY WAS CONDUCTED ON A TOTAL OF 711 EBUS-TBNA PROCEDURES FOR 635 PATIENTS FROM 2007 TO 2013. IN THE LITERATURE, IT WAS REPORTED THAT ONE PATIENT WAS ADMITTED FOR A PNEUMOTHORAX REQUIRING DRAINAGE ONE WEEK AFTER THE PROCEDURE. THE CONVEX PROBE EBUS (BF-UC160F-OL8, BF-UC180F-OL8) AND DEDICATED 22 OR 21 GAUGE NEEDLES (NA-201SX-4021, NA-201SX-4022) WERE USED FOR EBUS-TBNA. BASED ON THE AVAILABLE INFORMATION, REPORTED PNEUMOTHORAX WAS NOT REPORTED IN A DIRECT RELATIONSHIP WITH THE OLYMPUS PRODUCTS. HOWEVER, OMSC ASSUMES THAT THE PNEUMOTHORAX MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR THE PROCEDURE. AND, OMSC ASSUMES THAT THE PNEUMOTHORAX WITH HOSPITALIZATION MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THEREFORE, OMSC ASSUMES THAT THE PNEUMOTHORAX WAS AN ADVERSE EVENT TO SUBMIT. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENT WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MAL

  Patient problems: Pneumothorax

  MAUDE report 12030399 ↗
• MalfunctionOct 1, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS), WHILE COMPLETING THE FIRST SAMPLING PUNCTURE, THE NEEDLE BROKE OFF AND WAS STUCK IN THE PATIENT. AS A RESULT, THE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10616681 ↗
• MalfunctionOct 1, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS), WHILE COMPLETING THE FIRST SAMPLING PUNCTURE, THE NEEDLE BROKE OFF AND WAS STUCK IN THE PATIENT. AS A RESULT, THE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AS INTENDED. NO REPLACEMENT DEVICES WERE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613559 ↗