Single Use Aspiration Needle NA-U401SXRecalls & reported problems across all models
Olympus Medical Systems Corp. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Single Use Aspiration Needle NA-U401SX model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 227
- Deaths reported
- 1
- Injuries reported
- 59
- Recalls
- 2
We found 5 models of Single Use Aspiration Needle NA-U401SX by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 227 adverse event reports in the FDA's MAUDE database, received between May 25, 2018 and Sep 18, 2026 — classified as 1 death, 59 injuries, 167 malfunctions.
The most frequently reported specific device problem is “Break” (71 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Single Use Aspiration Needle NA-U401SX recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-1616-2023 · Root cause: Employee error · Recall details · FDA record ↗
- 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 Single Use Aspiration Needle NA-U401SX problems
Device problems
- Break71
- Detachment of Device or Device Component31
- Mechanical Problem13
- Material Twisted/Bent12
- Difficult to Advance11
- Material Split, Cut or Torn11
- Material Puncture/Hole10
- Material Separation10
Patient problems
- No Clinical Signs, Symptoms or Conditions183
- Foreign Body In Patient11
- No Consequences Or Impact To Patient8
- Insufficient Information6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Device Embedded In Tissue or Plaque4
- Unspecified Tissue Injury4
- Hemorrhage/Blood Loss/Bleeding3
Single Use Aspiration Needle NA-U401SX models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 1 recall94 reports
- 1 recall29 reports
- 51 reports
- 1 death32 reports
- 21 reports
Recent Single Use Aspiration Needle NA-U401SX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
Sheath of needle broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818354 ↗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 ↗MalfunctionSep 11, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739898 ↗MalfunctionAug 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510121 ↗MalfunctionAug 24, 2026Material Frayed; Difficult to Advance; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410655 ↗MalfunctionAug 19, 2026Device Damaged by Another Device; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324955 ↗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 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: Pneumothorax
MAUDE report 25058735 ↗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 ↗MalfunctionApr 28, 2026Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE ASPIRATION NEEDLE'S SHEATH WAS BUCKLED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018964 ↗MalfunctionApr 17, 2026Fracture
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE ASPIRATION NEEDLE'S INSERTION PORTION WAS SEVERED APPROXIMATELY 3 CM UNDER THE BOOT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24910743 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE DETACHED WHEN PULLING THE NEEDLE BACK UP THROUGH THE SCOPE. THE ISSUE OCCURRED DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION AND THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886190 ↗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 ↗
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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