Single Use Aspiration Needle NA-201SX-4022 (REF N5432340)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of Single Use Aspiration Needle (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170458385), received between Nov 20, 2025 and Apr 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Difficult to Advance1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗
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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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