Single Use Aspiration NeedleRecalls & reported problems across all models
Olympus Medical Systems Corp. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 292
- Deaths reported
- 2
- Injuries reported
- 83
- Recalls
- 0
We found 15 models of Single Use Aspiration Needle by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 292 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2018 and Sep 22, 2026 — classified as 2 deaths, 83 injuries, 207 malfunctions.
The most frequently reported specific device problem is “Break” (83 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Single Use Aspiration Needle problems
Device problems
- Break83
- Detachment of Device or Device Component52
- Material Split, Cut or Torn24
- Adverse Event Without Identified Device or Use Problem21
- Mechanical Problem19
- Material Twisted/Bent17
- Material Puncture/Hole16
- Physical Resistance/Sticking10
Patient problems
- No Clinical Signs, Symptoms or Conditions219
- No Consequences Or Impact To Patient15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Foreign Body In Patient11
- No Known Impact Or Consequence To Patient8
- Pneumothorax8
- Hemorrhage/Blood Loss/Bleeding6
- Fever5
Single Use Aspiration Needle models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use Aspiration Needle NA-201SX-4021Biopsy needle1 death126 reports
- Single Use Aspiration Needle NA-201SX-4022Biopsy needle1 death48 reports
- Single Use Aspiration Needle NA-201SX-4021Biopsy needle27 reports
- Single Use Aspiration Needle NA-201SX-4021Biopsy needle23 reports
- Single Use Aspiration Needle NA-201SX-4022Biopsy needle20 reports
- Single Use Aspiration Needle NA-201SX-4022Biopsy needle10 reports
- Single Use Aspiration Needle NA-201SX-4022Biopsy needle10 reports
- Single Use Aspiration Needle NA-201SX-4022Biopsy needle9 reports
- Single Use Aspiration Needle NA-U401SX-4025NBronchoscope accessory8 reports
- Single Use Aspiration Needle NA-201SX-4022Bronchoscope Accessory3 reports
- SINGLE USE ASPIRATION NEEDLE NA-200H-8022Biopsy needle2 reports
- Single Use Aspiration Needle NA-201SX-4022Biopsy needle2 reports
- Single Use Aspiration Needle NA-201SX-4022Biopsy needle2 reports
- Single Use Aspiration Needle NA-201SX-4022Biopsy needle1 report
- SINGLE USE ASPIRATION NEEDLE NA-U401SX-4025NBronchoscope accessory1 report
Recent Single Use Aspiration Needle adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
It was reported that the needle broke involving an Olympus Single Use Aspiration Needle. The issue occurred during a diagnostic Endobronchial Ultrasound (EBUS) procedure. The procedure was completed using a similar device. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852791 ↗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 ↗MalfunctionAug 26, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50461138 ↗MalfunctionApr 17, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE ASPIRATION NEEDLE WAS RETURNED SEVERED IN TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911056 ↗MalfunctionApr 16, 2026Material Puncture/Hole
IT WAS DISCOVERED DURING THE DEVICE EVALUATION, THE SHEATH ON THE OLYMPUS SINGLE-USE ASPIRATION NEEDLE HAD BEEN PUNCTURED BY THE NEEDLE ITSELF. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896200 ↗MalfunctionApr 14, 2026Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE-USE ASPIRATION NEEDLE'S INSERTION PORTION EXTENDED THROUGH BOTH THE HYPODERMIC TUBE AND SHEATH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24876926 ↗MalfunctionFeb 24, 2026No Apparent Adverse Event
IT WAS REPORTED THE SINGLE-USE ASPIRATION NEEDLE PUNCTURED THE MANDIBLE IN THE NEEDLE. THIS OCCURRED DURING AN ENDOBRONCHIAL ULTRASOUND 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 24429571 ↗MalfunctionJan 21, 2026Material Puncture/Hole; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24127905 ↗MalfunctionJan 6, 2026Difficult to Advance; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23979829 ↗MalfunctionDec 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE ASPIRATION NEEDLE'S PROXIMAL ATTACHMENT OF THE MANDREL ON THE FELL OFF. 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 23896452 ↗MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE EXHIBITED BROKE OFF. THE ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPE ENDOBRONCHIAL ULTRASOUND. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 23790149 ↗MalfunctionDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778290 ↗MalfunctionDec 2, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE EXPERIENCED LEAKING AT THE END OF THE PROCEDURE. THE ISSUE OCCURRED DURING A FIBROSCOPY / ECHO ENDOSCOPY PROCEDURE THAT WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700874 ↗MalfunctionNov 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE SHEATH HAD SHEARED AT THE TIP. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND (EBUS). THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23644875 ↗MalfunctionNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE KEPT FALLING OFF. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND AND WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23604223 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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