Single Use Aspiration Needle NA-U401SX NA-U401SX-4021 (UDI 04953170388248)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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus single-use aspiration needle has 93 adverse-event reports naming its identifier; reports mostly describe needle breakage, sheath splitting, or difficult advancement/retraction, sometimes with foreign body in patient, with no deaths and 40 injuries. An open recall started March 2023 over a needle angle not meeting manufacturing specifications, causing slight resistance during advancement and retraction. In the latest 12 months, 7 reports named it, versus 14 in the prior 12 months.
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
- 94
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 04953170388248), received between Mar 11, 2019 and Sep 11, 2026 — classified as 40 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Break” (30 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall 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
Recalls naming this device
- Mar 31, 2023Class IIIOpen, Classified
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Z-1615-2023 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Break30
- Detachment of Device or Device Component18
- Difficult to Advance8
- Material Separation8
- Retraction Problem6
- Fracture5
- Material Perforation4
- Material Puncture/Hole4
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- Foreign Body In Patient7
- No Consequences Or Impact To Patient4
- Unspecified Tissue Injury4
- Device Embedded In Tissue or Plaque3
- Insufficient Information3
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739898 ↗MalfunctionMay 5, 2026Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE NEEDLE TUBE ON THE SINGLE USE ASPIRATION NEEDLE BROKE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25080687 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE EXHIBITED SHEATH SPLITTING AFTER A COUPLE OF PASSES. THE ISSUE OCCURRED A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063102 ↗MalfunctionJan 12, 2026Break
IT WAS REPORTED THE SINGLE-USE ASPIRATION NEEDLE'S SHEATH WAS SPLITTING "AFTER A COUPLE OF PASSES". THIS WAS NOTED TO HAVE OCCURRED DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24038114 ↗MalfunctionJan 8, 2026Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003592 ↗MalfunctionDec 5, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733370 ↗MalfunctionNov 6, 2025Material Deformation; Material Deformation
NO NEW ADDITIONAL INFORMATION WAS REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493921 ↗MalfunctionNov 6, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484079 ↗MalfunctionSep 11, 2025Fracture; Fracture
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE END FELL OFF (THE TIP OF THE NEEDLE BROKE). THE ISSUE OCCURRED DURING SEDATION FOR A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) NEEDLE ASPIRATION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23028200 ↗MalfunctionSep 11, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE GUIDE GREEN SHEATH HAD SHREDDED AT THE END. THE ISSUE OCCURRED DURING A DIAGNOSTIC EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23027413 ↗MalfunctionSep 10, 2025Material Puncture/Hole; Material Puncture/Hole
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017102 ↗MalfunctionSep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE GUIDE SHAFT DETACHED FROM THE 21G NEEDLE AT THE DISTAL END. THE ISSUE OCCURRED DURING A DIAGNOSTIC EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992652 ↗MalfunctionSep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE GUIDE SHAFT DETACHED FROM THE 21G NEEDLE AT THE DISTAL END. THE ISSUE OCCURRED DURING A DIAGNOSTIC EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992520 ↗MalfunctionSep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE GUIDE SHAFT DETACHED FROM THE 21G NEEDLE AT THE DISTAL END. THE ISSUE OCCURRED DURING A DIAGNOSTIC EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992479 ↗MalfunctionSep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE GUIDE SHAFT DETACHED FROM THE 21G NEEDLE AT THE DISTAL END. THE ISSUE OCCURRED DURING A DIAGNOSTIC EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992389 ↗MalfunctionAug 22, 2025Fracture; Fracture
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE NA-U401SX'S PUNCTURE NEEDLE WAS FRACTURED INTERNALLY. SERVICE / MAINTENANCE (NOT IN A CLINICAL SETTING). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22872131 ↗MalfunctionJun 30, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE SHEATH WAS BUCKLING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359067 ↗MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ASPIRATION NEEDLE WAS DEPLOYED AND INSIDE OF THE PATIENT'S NODE FOR SAMPLE COLLECTION. WHEN THE DOCTOR ATTEMPTED TO RETRACT THE NEEDLE BACK INTO THE SHEATH FOR REMOVAL, THE CONNECTION BETWEEN THE NEEDLE AND HANDLE HAD BEEN SEVERED. UNABLE TO REMOVE THE NEEDLE FROM THE NODE, THE SHEATH WAS RETRACTED BACK AS FAR AS IT WOULD GO, AND THE NEEDLE AND ENTIRE SCOPE WERE CAREFULLY REMOVED SIMULTANEOUSLY. THE ISSUE WAS OBSERVED DURING BRONCHOSCOPY WITH BRONCHIAL ALVEOLAR LAVAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346194 ↗MalfunctionJun 25, 2025Material Too Rigid or Stiff; Failure to Fire; Material Deformation; Material Too Rigid or Stiff; Failure to Fire; Material Deformation
IT WAS REPORTED THE SUBJECT DEVICE HANDLE MECHANISM WAS OVERLY STIFF WHICH CAUSED PROBLEMS DEPLOYING THE NEEDLE PROPERLY AND CAUSED THE NEEDLE TIP TO BEND. THIS EVENT OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR OLYMPUS DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT ONE OF FOUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22330667 ↗MalfunctionMay 29, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22108963 ↗MalfunctionMay 21, 2025Material Frayed; Material Frayed
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE SHEATH 'FRAYED' OR, RATHER, BECAME IRREPARABLY DEFORMED AT THE DISTAL END, NO LONGER ALLOWING THE NEEDLE TO EXIT SMOOTHLY. THE ISSUE WAS DISCOVERED DURING THE NEEDLE ASPIRATION PROCEDURE. THE NEEDLE WAS REPLACED BY A SIMILAR ONE FROM THE SAME PACKAGE, WHICH, AT THE SAME TIME, BECAME IRREPARABLY DEFORMED AFTER 3 PASSES THROUGH THE LYMPH NODE. DURING THE PRIOR INSPECTION, THE NEEDLE HAD NO DEFECTS OR MALFUNCTIONS. THE PATIENT DID NOT SUFFER ANY CONSEQUENCES, EXCEPT FOR A SLIGHT PROLONGATION OF SEDATION (8/10 MINUTES).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22065309 ↗MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THE SUBJECT DEVICE SILVER METAL PART (APPENDIX) OF THE NEEDLE CAME OUT WHEN THE NEEDLE WAS WITHDRAWN. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT HARM WAS REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21697867 ↗MalfunctionOct 11, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE STOPPED WORKING MID-CASE, AS THE TIP OF THE NEEDLE DEFORMED IN AN UNUSUAL WAY (LOOKS LIKE A BURR). THE ISSUE WAS FOUND DURING AN UNSPECIFIED BIOPSY WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433918 ↗MalfunctionJul 8, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE ASPIRATION NEEDLE SLIPS AND DOES NOT STAY IN PLACE. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE (ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL). THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19698001 ↗MalfunctionMay 27, 2024Retraction Problem; Retraction Problem
SINGLE USE ASPIRATION NEEDLE WAS RETURNED FOR EVALUATION ALTHOUGH IT WAS CONFIRMED THAT THIS NEEDLE WAS NOT INVOLVED IN A PATIENT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19402222 ↗
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-1616-2023 · Mar 31, 2023 · Open, ClassifiedTo 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
- MAGNUM MN1410Bard Peripheral Vascular, Inc. · Biopsy needle1 recall118 reports
- EchoTip G31520Cook Ireland Ltd · Biopsy needle1 recall84 reports
- Single Use Aspiration Needle NA-201SX-4021Olympus Medical Systems Corp. · Biopsy needle1 death126 reports
- EchoTip ProCore G34785Cook Ireland Ltd · Biopsy needle97 reports
- MAGNUM MN1820Bard Peripheral Vascular, Inc. · Biopsy needle1 recall37 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4022Olympus Medical Systems Corp. · Biopsy needle1 recall29 reports
- Interject M00518250Boston Scientific Corporation · Biopsy needle70 reports
- EchoTip G52012Cook Ireland Ltd · Biopsy needle1 recall18 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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