Single Use Aspiration Needle NA-201SX-4022 (UDI 04953170381928)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170381928), received between Oct 24, 2019 and Sep 1, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Detachment of Device or Device Component

  It was reported the single use aspiration needle came out when removing the guide wire during a transbronchial needle aspiration 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 50550834 ↗
• MalfunctionMar 4, 2025Contamination; Contamination

  IT WAS REPORTED THE NEEDLE HAD A STRANGE RESIDUE FOUND ON THE STYLET FOR THE NEEDLE WHEN CLEANING THE SYLET. THE EVENT OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518035 ↗
• InjuryNov 19, 2024Fracture; Fracture

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20719083 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 25, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "HEMOTHORAX AFTER ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION¿. THE PURPOSE OF THE LITERATURE WAS TO REPORT A CASE OF HEMOTHORAX AFTER ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) IN A PATIENT WITH A RIGHT UPPER LOBE MASS. THE EBUS-TBNA WAS PERFORMED USING A BRONCHOSCOPE (BF-UC160F) AND A NEEDLE (NA-201SX-4022). IN THE LITERATURE, IT WAS REPORTED A CASE OF HEMOTHORAX 24 HOURS AFTER EBUS-TBNA AS BELLOW. ¿TWENTY-FOUR HOURS AFTER THE PROCEDURE THE PATIENT COMPLAINED OF INCREASING DYSPNEA AND RIGHT-SIDED PLEURITIC CHEST PAIN. HEMOGLOBIN FELL TO 49 G/L AND A CT SCAN SHOWED A HIGH ATTENUATION RIGHT-SIDED PLEURAL EFFUSION (FIG. 2). A DIAGNOSTIC THORACOCENTESIS REVEALED A BLOODY PLEURAL EFFUSION WITH PLEURAL FLUID HEMATOCRIT >50% OF THE PERIPHERAL BLOOD HEMATOCRIT (0.18 VS. 0.22) CONFIRMING THAT A HEMOTHORAX WAS PRESENT, AND A CHEST TUBE WAS PLACED WITH COMPLETE RECOVERY WITHIN 3 DAYS.¿ AFTERWARD, UNDERSTANDING A COLONOSCOPY, HE WAS DIAGNOSED WITH ADVANCED, STAGE IV LUNG ADENOCARCINOMA, AND SYNCHRONOUS SIGMOID ADENOCARCINOMA ARISING FROM TUBULOVILLOUS ADENOMA. CH

  Patient problems: Hemothorax

  MAUDE report 12768090 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUN 12, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "RISKS AND BENEFITS IN TREATMENT OF MEDIASTINAL ABSCESS BY ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION". THIS STUDY WAS CONDUCTED ON THE ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) FOR MEDIASTINAL ABSCESS PATIENT. IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; THIS STUDY AIMS TO REPORT A CASE OF MEDIASTINAL ABSCESS WITH COMPLICATIONS OF PNEUMONIA AND SEPSIS CAUSED BY EBUS-TBNA BUT SUBSEQUENTLY TREATED BY EBUS-TBNA SUCCESSFULLY. A (B)(6) YEAR-OLD MAN PRESENTED WITH TRANSIENT HIGH FEVER (39.38C) IN CONJUNCTION WITH A SIX-MONTH-LONG HISTORY OF DRY COUGH, CHEST COMPUTED TOMOGRAPHY (CT) SHOWED A NON-ENHANCING MASS IN THE SUBCARINAL REGION. EBUS SCAN (CP-EBUS) DEMONSTRATED AN APPROXIMATELY 23.4 * 20.0 MM SIZED HETEROGENEOUS, HYPOECHOIC, CYSTIC LESION IN THE SUBCARINAL REGION. TBNA WAS THEN APPLIED AND ROUGHLY 11 ML OF YELLOWISH MUCOPURULENT MATERIAL WAS THEN ASPIRATED USING A DEDICATED 22-GAUGE NEEDLE (NA-201SX-4022). THE MICROBIAL TEST FROM THE INITIAL EBUSTBNA SPECIMEN OF THE LESION SHOWED ALL NEGATIVE RESULTS. DESPITE RECOMMENDING INPATIENT TREATME

  Patient problems: Pneumonia; Sepsis

  MAUDE report 12230933 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, OMSC RECEIVED THE DOCUMENT "MEDIASTINAL HEMATOMA FOLLOWING ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION". THE PURPOSE OF THE LITERATURE WAS TO DISCUSS ONE OF THE POTENTIAL HAZARDS FOR THIS TECHNIQUE WHICH IS INJURY OF MEDIASTINAL VESSELS. THE PROCEDURE WAS PERFORMED USING A NEEDLE (OLYMPUS; NA-201SX-4022) AND FLEXIBLE BRONCHOSCOPE FOR ENDOBRONCHIAL ULTRASOUND (EBUS) (OLYMPUS; BF-UC160F-OL8). A MALE PATIENT AGED (B)(6) PRESENTED TO OUR HOSPITAL WITH MANIFESTATIONS OF LOWER RESPIRATORY TRACT INFECTION INCLUDING PRODUCTIVE COUGH AND MODERATE DYSPNEA. THE PATIENT WAS CHRONIC SMOKER (40 PACK/ YEAR). X-RAY WAS PERFORMED AND A NODULE IN THE RIGHT LUNG WAS INCIDENTALLY DISCOVERED. COMPUTED TOMOGRAPHY (CT) OF CHEST CONFIRMED THE DIAGNOSIS OF SOLITARY PULMONARY NODULE IN RIGHT UPPER LOBE WITH SPECULATED MARGINS, HETEROGENOUS CONTRAST, MEASURING 18 ×15 ×19 MM. THE LITERATURE WROTE, ¿DURING THE INTERVENTION, THE OPERATORS SAFELY SAMPLED STATION 11L AND WHILE SAMPLING STATION 4L, ALTHOUGH THE AORTIC BORDER WAS CLEARLY VISIBLE AND CAUTIOUSLY AVOIDED, THE OPERATORS NOTICED DISTURBANCE IN THE ULTRASONOGRAPHIC IMAGES ASSOCIATED WITH LOSS OF RELATIONSHIP BETWEEN A

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Strangulation

  MAUDE report 12193773 ↗
• MalfunctionAug 13, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS), WHILE ADDRESSING THE 4R NODE USING THE NEEDLE, THERE WAS EXTREME ANGULATION GOING THROUGH CARTILAGE. ON THE SECOND PASS THE NEEDLE TIP BROKE OFF IN THE TISSUE. THE TIP WAS RETRIEVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10405602 ↗
• MalfunctionJul 14, 2020Break; Break

  THE SERVICE CENTER WAS INFORMED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE LOCKING MECHANISM OF THE VIZISHOT NEEDLE WOULD NOT LOCK. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 10272394 ↗
• MalfunctionOct 24, 2019Break; Break

  DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANS-BRONCHIAL NEEDLE ASPIRATION, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE USER CONFIRMED THAT A FOREIGN BODY WAS DETECTED IN THE PATIENT. THE FOREIGN BODY WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FOREIGN BODY DETECTED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9236603 ↗