Single Use Aspiration Needle NA-201SX-4021Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170458378), received between Sep 12, 2025 and Sep 29, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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, 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
- Material Split, Cut or Torn3
- Break1
- Fluid/Blood Leak1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932259 ↗MalfunctionAug 18, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308969 ↗MalfunctionAug 18, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308826 ↗MalfunctionOct 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23395577 ↗InjurySep 18, 2025Break; Break
IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, UNDER SEDATION AFTER A FEW PUNCTURES OF LESION WERE MADE WITH SINGLE USE ASPIRATION NEEDLE (UNSPECIFIED PROCEDURE), THE NURSE WAS PULLING THE STYLET BACK AND THE PLASTIC TIP OF THE STYLET BROKE OFF. TO ENSURE STYLET WAS INSIDE THE DEVICE AND THE NEEDLE, THE NURSE USED A FB-433D FORCEPS TO GRAB THE NEEDLE FROM THE OPENING OF THE DEVICE TO PULL THE STYLET WIRE BACK AND THE DEVICE WAS RETRIEVED. A CT SCAN WAS DONE TO ENSURE THAT THERE WERE NO REMAINS OF THE STYLET WIRE IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23092460 ↗MalfunctionSep 12, 2025Material Puncture/Hole; Material Puncture/Hole
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23041000 ↗
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- CRE Pulmonary M00550340Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY26 reports
- CRE Pulmonary M00550310Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY21 reports
- CRE Pulmonary M00550350Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY21 reports
- CRE Pulmonary M00550330Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY20 reports
- CRE Pulmonary M00550320Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY15 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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