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Single Use Aspiration Needle NA-U401SX NA-U401SX-4022 (UDI 04953170388323)Recalls & reported problems

Olympus Medical Systems Corp. · Class 2

All models of Single Use Aspiration Needle NA-U401SX (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Olympus single-use aspiration needle is used to take samples during endobronchial ultrasound and other biopsy procedures. The 32 reports mostly describe the needle or its sheath breaking, detaching, or puncturing through its channel, sometimes leaving fragments in the patient's lung or injuring the trachea; 1 death and 12 injuries were reported, along with 19 malfunctions. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
32
Deaths reported
1
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04953170388323), received between May 12, 2021 and May 1, 2026 — classified as 1 death, 12 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

2 other recalls 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.

Reports received per month

Nov 2023: 3 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break11
  • Adverse Event Without Identified Device or Use Problem5
  • Detachment of Device or Device Component5
  • Mechanical Problem4
  • Premature Activation2
  • Activation, Positioning or Separation Problem1
  • Device Damaged by Another Device1
  • Device Fell1

Patient problems

  • No Clinical Signs, Symptoms or Conditions23
  • Foreign Body In Patient3
  • Hemorrhage/Blood Loss/Bleeding3
  • Pneumothorax2
  • Abscess1
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Chest Pain1
  • Confusion/ Disorientation1

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: Pneumothorax

    MAUDE report 25058735 ↗
  • InjuryNov 20, 2025Material Puncture/Hole; Device Damaged by Another Device; Mechanical Jam; Material Puncture/Hole; Device Damaged by Another Device; Mechanical Jam

    IT WAS REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE, THE ASPIRATION NEEDLE WAS OBSTRUCTED IN THE CHANNEL, PUNCTURED THE SCOPE, AND DAMAGED THE PATIENT¿S TRACHEA. THE EXTENT AND SEVERITY OF THE TRACHEAL INJURY ARE UNKNOWN. THE PROCEDURE WAS COMPLETED USING A BACKUP SCOPE AND A NEW ASPIRATION NEEDLE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS EVENT INCLUDES 2 REPORTS. THIS REPORT IS 1 OF 2.

    Patient problems: Upper Respiratory Tract Injury

    MAUDE report 23609484 ↗
  • MalfunctionNov 23, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED, THE SUBJECT DEVICE HAD THE NEEDLE TIP WAS BENT. THE ISSUE WAS FOUND, DURING A THERAPEUTIC EBUS-TBNA. THE PROCEDURE COMPLETED BY THE BACKUP OLYMPUS DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. .

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20767018 ↗
  • MalfunctionOct 24, 2024Unintended Movement; Unintended Movement

    IT WAS REPORTED, THAT THE SINGLE USE ASPIRATION NEEDLE SHEATH MOVED WHEN TRYING TO EXTEND THE NEEDLE. THE ISSUE WAS FOUND, DURING A DIAGNOSTIC EBUS BRONCHOSCOPY. THE PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20522331 ↗
  • InjurySep 9, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE SHEATH OF THE SUBJECT DEVICE BROKE OFF DURING AN UNSPECIFIED PROCEDURE, FELL INTO THE PATIENT'S LUNG, AND WAS RECOVERED USING FORCEPS. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20170325 ↗
  • MalfunctionJul 22, 2024Material Perforation; Material Perforation

    IT WAS REPORTED THE ASPIRATION NEEDLE PIERCED THROUGH THE SHEATH. THE SCOPE AND THE NEEDLE WERE REMOVED. THE ISSUE OCCURRED DURING A GASTROENTEROLOGY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19798266 ↗
  • MalfunctionJul 5, 2024Problem with Sterilization; Problem with Sterilization

    IT WAS REPORTED THE ASPIRATION NEEDLE EXPERIENCED HOLE/IRREGULARITY IN THE SEALED STERILE PACKAGE. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19684386 ↗
  • MalfunctionJun 11, 2024Break; Mechanical Problem; Break; Mechanical Problem

    IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE WOULD NOT COME OUT FROM THE TIP, THE NEEDLE HAD BROKEN OFF. THE ISSUE OCCURRED DURING AN UNKNOWN SURGERY PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER REPLACING IT WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19513137 ↗
  • InjuryJan 29, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    THE CUSTOMER REPORTED, DURING A BRONCHIAL ULTRASOUND ENDOSCOPY, THE ENDOSCOPIC ECHO NEEDLE BROKE DURING A PUNCTURE ON THE POSTERIOR ASPECT OF THE TRACHEA. THE EXTREMITY REMAINED PLANTED IN THE TRACHEA. THE OPERATOR ATTEMPTED TO REMOVE THE NEEDLE WITH BIOPSY FORCEPS BUT THE NEEDLE SLIPPED AND FELL INTO THE DISTAL PART OF THE BRONCHIAL TREE. THE PATIENT SPAT OUT THE NEEDLE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18602812 ↗
  • InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE ADVERSE EVENTS AND THE OLYMPUS DEVICE. THE HYPOXEMIA WAS DUE TO THE PATIENT'S ORIGINAL CONDITION AND THE BLEEDING COMPLICATION WAS DUE TO A PROCEDURAL PROBLEM.

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

    MAUDE report 18172812 ↗
  • InjuryNov 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    A USER FACILITY REPORTED TO OLYMPUS DURING A DIAGNOSTIC ENDOSCOPIC BRONCHIAL ULTRASOUND "EUBU" WITH FINE NEEDLE ASPIRATION PROCEDURE THE NEEDLE BROKE INSIDE THE PATIENT. THE CUSTOMER REPORTED THEY ARE MISSING 2 INCHES AND COULD NOT FIND IT. THE DEVICE WAS INSPECTED PRIOR TO USE. VISUAL INSPECTION, X-RAY, AND CT SCAN WERE PERFORMED. THE CUSTOMER LATER CONFIRMED THE PROCEDURE WAS COMPLETED AND THE PATIENT'S ANESTHESIA WAS DELAYED BY 60 MINUTES. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL, ALTHOUGH HAD AN EXTENDED TIME IN PHASE II WHILE WAITING FOR THE CT RESULTS. THERE WAS NO EVIDENCE ON VISUAL INSPECTION, X-RAY, AND CT SCAN THAT THE NEEDLE REMAINED IN THE PATIENT. THE NEEDLE WAS NEVER CONFIRMED TO REMAIN INSIDE THE PATIENT. THERE HAS BEEN NO FURTHER EVENTS OR HARM TO THE PATIENT. PATIENT IS STABLE AND AT HOME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18132876 ↗
  • InjuryNov 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    A USER FACILITY REPORTED TO OLYMPUS DURING A DIAGNOSTIC ENDOSCOPIC BRONCHIAL ULTRASOUND "EUBU" WITH FINE NEEDLE ASPIRATION PROCEDURE THE NEEDLE BROKE INSIDE THE PATIENT. THE CUSTOMER REPORTED THEY ARE MISSING 2 INCHES AND COULD NOT FIND IT. THE DEVICE WAS INSPECTED PRIOR TO USE. VISUAL INSPECTION, X-RAY, AND CT SCAN WERE PERFORMED. THE CUSTOMER LATER CONFIRMED THE PROCEDURE WAS COMPLETED AND THE PATIENT'S ANESTHESIA WAS DELAYED BY 60 MINUTES. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL, ALTHOUGH HAD AN EXTENDED TIME IN PHASE II WHILE WAITING FOR THE CT RESULTS. THERE WAS NO EVIDENCE ON VISUAL INSPECTION, X-RAY, AND CT SCAN THAT THE NEEDLE REMAINED IN THE PATIENT. THE NEEDLE WAS NEVER CONFIRMED TO REMAIN INSIDE THE PATIENT. THERE HAS BEEN NO FURTHER EVENTS OR HARM TO THE PATIENT. PATIENT IS STABLE AND AT HOME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18132653 ↗
  • MalfunctionOct 6, 2023Break; Break

    A CLINICAL SPECIALIST REPORTED TO OLYMPUS, (3) SINGLE USE ASPIRATION NEEDLES WERE MELTED, AND DISTAL END OF THE SHEATH WAS BROKEN. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17891558 ↗
  • MalfunctionOct 6, 2023Break; Break

    A CLINICAL SPECIALIST REPORTED TO OLYMPUS, (3) SINGLE USE ASPIRATION NEEDLES WERE MELTED, AND DISTAL END OF THE SHEATH WAS BROKEN. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6), AND (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17891328 ↗
  • MalfunctionOct 6, 2023Break; Break

    A CLINICAL SPECIALIST REPORTED TO OLYMPUS, (3) SINGLE USE ASPIRATION NEEDLES WERE MELTED, AND DISTAL END OF THE SHEATH WAS BROKEN. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17891067 ↗
  • MalfunctionSep 28, 2023No Display/Image; No Display/Image

    AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER THAT IT WAS HARDER THAN USUAL TO SEE THE SINGLE USE ASPIRATION NEEDLE TIP UNDER THE ULTRASOUND IMAGE. THE UNSPECIFIED DIAGNOSTIC PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17840857 ↗
  • MalfunctionAug 22, 2023Break; Break

    THE CUSTOMER REPORTED THAT THE NEEDLE BROKE WHILE USING IT. THE REPORTED ISSUE WAS OBSERVED DURING A THERAPEUTIC EBUS (ENDOBRONCHIAL ULTRASOUND) BRONCHOSCOPY. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITHOUT A DELAY. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17600057 ↗
  • MalfunctionAug 19, 2023Leak/Splash; Leak/Splash

    THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE SINGLE USE ASPIRATION NEEDLE DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL FINE NEEDLE ASPIRATION PROCEDURE, LEAKAGE OCCURRED FROM THE JOINT OF THE DEVICE (BODY FLUID WHEN ASPIRATED). THE PROCEDURE WAS COMPLETED BY SWITCHING TO A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17581127 ↗
  • InjuryJul 25, 2023Break; Break

    THE CUSTOMER REPORTED TO THE NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS (ANSM) AND THEN TO OLYMPUS THE SINGLE USE ASPIRATION NEEDLE BROKE OFF AND THE DISTAL FRAGMENT (APPROXIMATELY 1 CENTIMETER) REMAINED STUCK IN THE BRONCHIAL WALL. THE ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHIAL ENDOSCOPY AND PUNCTURE BIOPSY OF THE LYMPH NODES. THE PROCEDURE WAS EXTENDED BY 45-MINUTES WHILE THE USER ATTEMPTED TO RETRIEVE THE BROKEN FRAGMENT BUT WAS UNSUCCESSFUL. AN X-RAY AND THORACIC CT AT D+1 WERE PERFORMED TO TRY TO LOCATE THE FRAGMENT BUT WERE ALSO UNSUCCESSFUL. WITHOUT THE LOCATION OF THE BROKEN DEVICE BEING CLEAR, THERE CAN BE NO PLAN TO RECOVER IT. THERE WERE NO REPORTS OF HEMORRHAGIC HARM, AND NO ADDITIONAL REPORTS OF PATIENT IMPACT.

    Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

    MAUDE report 17392737 ↗
  • MalfunctionJul 12, 2023Premature Activation; Premature Activation

    THE CUSTOMER REPORTED THAT THE VACLOCK RUBBER FELL OFF WITHIN THE SYRINGE, RESULTING IN THE SYRINGE BEING UNABLE TO PROVIDE SUCTION. ADDITIONALLY, IT WAS REPORTED THAT THE NEEDLE WAS NOT LOCKED WHEN IT CAME OUT OF THE PLASTIC CONTAINER, AND IT DEPLOYED WHEN THEY WERE PUTTING IT INTO THEIR ENDOBRONCHIAL ULTRASOUND SCOPE. THE REPORTED ISSUE WAS OBSERVED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PROCEDURAL IMPACT AS A RESULT OF THE ISSUE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION OF UNABLE TO LOCK THE NEEDLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17309815 ↗
  • MalfunctionJun 7, 2023Premature Activation; Detachment of Device or Device Component; Premature Activation; Detachment of Device or Device Component

    AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT, DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE, A RUBBER LOCKING COMPONENT (VACLOK) OF THE CUSTOMER¿S SINGLE USE ASPIRATION NEEDLE DISLODGED WITHIN THE SYRINGE, RESULTING IN THE SYRINGE BEING UNABLE TO PROVIDE SUCTION. ADDITIONALLY, IT WAS REPORTED THAT THE NEEDLE WAS NOT LOCKED WHEN IT CAME OUT OF THE PLASTIC CONTAINER, AND IT DEPLOYED WHEN THEY WERE PUTTING IT INTO THEIR ENDOBRONCHIAL ULTRASOUND SCOPE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PROCEDURAL IMPACT AS A RESULT OF THE ISSUE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17084092 ↗
  • InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FEASIBILITY OF MODIFIED ENDOBRONCHIAL ULTRASOUND-GUIDED INTRANODAL FORCEPS BIOPSY: A RETROSPECTIVE ANALYSIS." THE RETROSPECTIVE STUDY WAS TO ASSESS THE FEASIBILITY OF THE MODIFIED EBUS- INTRANODAL FORCEPS BIOPSY (IFB) TECHNIQUE, WHICH COMBINES STANDARD-SIZED FORCEPS WITH STANDARD ENDOBRONCHIAL ULTRASOUND (EBUS) TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) EQUIPMENT. A TOTAL OF 195 PATIENTS WERE INCLUDED. IFB WAS TECHNICALLY SUCCESSFUL IN 177 OF 195 CASES (90.8%). THE DIAGNOSTIC ACCURACY WAS 99.5% (193 OF 194 CASES). ONE PATIENT WAS LOST TO FOLLOW-UP. UNIVARIABLE ANALYSES DID NOT IDENTIFY ANY FACTORS INVOLVED IN TECHNICAL IFB FAILURE. AMONG THE DIAGNOSED CASES, THREE (1.5%) WERE DIAGNOSED. THE MEDIAN (RANGE) HISTOLOGICAL SCORES OF TBNA AND IFB SPECIMENS WERE 1.50 (0¿2) AND 1.67 (0¿2), RESPECTIVELY, WHICH WERE SIGNIFICANTLY DIFFERENT (P = 0.032). IN CONCLUSION, MODIFIED EBUS-IFB, COMBINING STANDARD-SIZED FORCEPS AND THE USUAL EQUIPMENT FOR EBUS TBNA, IS FEASIBLE WITH FEW MAJOR COMPLICATIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PNEUMONIA - 1 PATIENT, PNEUMOTHORAX REQUIRING THORACIC DRAINAGE - 1 PATIENT, MINOR BLEEDING - 25 PATIENTS.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumonia; Pneumothorax

    MAUDE report 16765401 ↗
  • InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT IS REPORTED IN THE LITERATURE ARTICLE TITLED ¿COMPARISON OF ULTRASONIC BRONCHOSCOPE UC290F AND UC260FW AT OUR HOSPITAL¿; PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS NA-403D-2021. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS BF-UC260FW. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS BF-UC290F. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS NA-U401SX-4022. BACKGROUND: THE ULTRASONIC BRONCHOSCOPE IS EFFECTIVE FOR COLLECTING SPECIMENS OF LESIONS IN CONTACT WITH THE CENTRAL AIRWAY, AND WE HAVE INTRODUCED THE ULTRASONIC BRONCHOSCOPE UC290F SINCE SEPTEMBER 2020. WE REPORT THIS BECAUSE WE EXAMINED THE COMPARISON WITH THE UC260FW THAT WAS USED UNTIL THEN. METHOD: FROM NOVEMBER 2019 TO NOVEMBER 2021, 177 CASES USING AN ULTRASONIC BRONCHOSCOPE WERE RETROSPECTIVELY EXAMINED AT OUR HOSPITAL. RESULTS: MEDIAN AGE 71 YEARS (24-84 YEARS). 125 MALES AND 52 FEMALES. UC290F 49 CASES, BIOPSY NEEDLE VISISHOT2 22G 48 CASES, VISISHOT 19G 1 CASE, AVERAGE NUMBER OF BIOPSIES 4.1 TIMES. UC260FW 128 CASES, BIOPSY NEEDLE VISISHOT2 22G 116 CASES, COOK22G L 1 CASE, COOK25G 1 CASE, AVERAGE NUMBER OF BIOPSIES 4.1 TIMES. THE BIOPSY SIT

    Patient problems: Abscess; Hemorrhage/Blood Loss/Bleeding; Hypoxia; Perforation of Vessels

    MAUDE report 14642264 ↗
  • InjuryApr 22, 2022Separation Problem; Separation Problem

    THE CUSTOMER REPORTED DURING AN UNKNOWN PROCEDURE, THE ASPIRATION NEEDLE AT THE END WAS LOST AND FELL INTO THE PATIENT'S LUNG. IT DISLODGED IN THE LUNG AND WAS RETRIEVED WITH FORCEPS. DURING RETRIEVAL, THE NEEDLE FELL AGAIN, CLOSE TO THE PATIENT'S ESOPHAGUS, IN THEIR AIRWAY. THE NEEDLE WAS RETRIEVED AGAIN AND REMOVED FROM THE PATIENT. THE CUSTOMER WAS UNAWARE OF ANY ADDITIONAL ISSUES WITH THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 14189660 ↗
  • InjuryApr 22, 2022Device Fell

    THE CUSTOMER REPORTED DURING AN UNKNOWN PROCEDURE, THE ASPIRATION NEEDLE AT THE END WAS LOST AND FELL INTO THE PATIENT'S LUNG. IT DISLODGED IN THE LUNG AND WAS RETRIEVED WITH FORCEPS. DURING RETRIEVAL, THE NEEDLE FELL AGAIN, CLOSE TO THE PATIENT'S ESOPHAGUS, IN THEIR AIRWAY. THE NEEDLE WAS RETRIEVED AGAIN AND REMOVED FROM THE PATIENT. THE CUSTOMER WAS UNAWARE OF ANY ADDITIONAL ISSUES WITH THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 14189632 ↗

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
  • Z-1616-2023 · Mar 31, 2023 · Open, Classified
    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal

Other Biopsy needle devices

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Sources and updates

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