Single Use Aspiration Needle NA-U401SX NA-U401SX-4022 (REF R5000692)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
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04953170409981), received between Feb 26, 2025 and Sep 15, 2026 — classified as 2 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
Most reported problems
Device problems
- Break8
- Detachment of Device or Device Component3
- Material Twisted/Bent3
- Device Damaged Prior to Use1
- Device Dislodged or Dislocated1
- Material Integrity Problem1
- Material Separation1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781452 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781444 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779358 ↗MalfunctionAug 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510121 ↗MalfunctionApr 29, 2026Unintended Movement
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE THE BIOPSY NEEDLE WHICH WAS SUPPOSED TO BE LOCKED MOVED. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035488 ↗MalfunctionMar 6, 2026
SHEATH WOULD NOT SIT PROPERLY ON THE NEEDLE FOR EBUS IT KEPT RETRACTING DURING EBUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531189 ↗MalfunctionMar 4, 2026
NEEDLE SHEATH KEPT SLIPPING WHILE TRYING TO TAKE SAMPLES
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505689 ↗MalfunctionMar 3, 2026Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE ASPIRATION NEEDLE EXHIBITED THE TIP OF THE INSERTION PART WAS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24502975 ↗MalfunctionFeb 12, 2026Detachment of Device or Device Component
IT WAS REPORTED DURING A BRONCHIAL ENDOSCOPIC ULTRASOUND, AFTER THE FIRST PASS, THE PROTECTIVE SHEATH DETACHED FROM THE HANDLE OF THE SINGLE USE ASPIRATION NEEDLE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327424 ↗InjuryJan 7, 2026Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23989265 ↗MalfunctionDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23908519 ↗MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE HAD A PROTECTIVE SHEATH THAT FELL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905992 ↗InjuryDec 18, 2025Material Separation; Material Separation
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846781 ↗MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23811854 ↗MalfunctionOct 16, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23318059 ↗MalfunctionAug 25, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22883356 ↗MalfunctionJul 15, 2025Break; Break
IT WAS REPORTED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE, THE NEEDLE BROKE OFF IN THE WORKING CHANNEL OF SCOPE. THE NEEDLE WAS REPLACED WITH AN OLYMPUS BACK-UP DEVICE. THERE WAS NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22512904 ↗MalfunctionJul 11, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22487945 ↗MalfunctionMay 14, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22021993 ↗MalfunctionMar 12, 2025Device Damaged Prior to Use; Device Damaged Prior to Use
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21588135 ↗MalfunctionFeb 26, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21474610 ↗
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, ClassifiedViziShot 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, 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
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4021Olympus Medical Systems Corp. · Biopsy needle1 recall94 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
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
- 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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