SINGLE USE ASPIRATION NEEDLE NA-U401SX-4025N (UDI 04953170402012)Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Aspiration Needle NA-U401SX-4025N · Class 2
All models of Single Use Aspiration Needle (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170402012), received between Feb 11, 2021 and Feb 11, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2021Material Separation; Material Separation
IT IS REPORTED DURING A THERAPEUTIC BRONCHOSCOPY USING A SINGLE USE ASPIRATION NEEDLE, THE NEEDLE BROKE DURING THE LAST PAST DURING THE BRONCHOSCOPY ULTRASOUND PORTION OF THE PROCEDURE. THE NEEDLE FELL INTO THE PATIENT'S LUNG AND WAS RETRIEVED WITH FORCEPS. THERE WAS NO INJURY OR DELAY. THE PHYSICIAN DETERMINED THE YIELD WAS GOOD AS MULTIPLE PASSES WERE COMPLETED BEFORE THE INCIDENT OCCURRED. PATIENT'S CURRENT CONDITION IS REPORTED TO BE THE SAME AS PRE-PROCEDURE AS THERE WAS NO INJURY TO THE PATIENT AND NO TREATMENT WAS REQUIRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11314592 ↗
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- CRE Pulmonary M00550350Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY21 reports
- CRE Pulmonary M00550330Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY20 reports
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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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