Single Use Aspiration Needle NA-U200H NA-U200H-8025Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of Single Use Aspiration Needle NA-U200H (5)
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 04953170402500), received between May 7, 2024 and Jun 17, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Expiration Date Error1
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.
MalfunctionJun 17, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THE SUBJECT DEVICE EXPIRATION ON THE BOX STATES 2/28/2025 AND THE EXPIRATION ON DEVICE WAS 4/30/2026. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22237871 ↗MalfunctionMay 24, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED THE ASPIRATION NEEDLE WAS UNABLE TO BE INSERTED INTO THE STYLET. THE ISSUE OCCURRED DURING A GASTROINTESTINAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19393079 ↗MalfunctionMay 7, 2024
OPENED PACKAGE. INSERTED NEEDLE THROUGH ENDOSCOPE INTO BIOPSY SITE. REMOVED THE STYLET. USED NEEDLE TO TAKE BIOPSY. PUSHED BIOPSY OUT WITH STYLET. REMOVED STYLET AGAIN. FLUSHED WITH SALINE, THEN AIR. TRIED TO REPLACE STYLET, BUT WOULD NOT INSERT FULLY INTO THE NEEDLE AFTER REPEATED ATTEMPTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19258676 ↗
Other Biopsy needle devices
- MAGNUM MN1410Bard Peripheral Vascular, Inc. · Biopsy needle1 recall118 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4021Olympus Medical Systems Corp. · Biopsy needle1 recall94 reports
- EchoTip G31520Cook Ireland Ltd · Biopsy needle1 recall84 reports
- Single Use Aspiration Needle NA-201SX-4021Olympus Medical Systems Corp. · Biopsy needle1 death126 reports
- EchoTip ProCore G34785Cook Ireland Ltd · Biopsy needle97 reports
- MAGNUM MN1820Bard Peripheral Vascular, Inc. · Biopsy needle1 recall37 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4022Olympus Medical Systems Corp. · Biopsy needle1 recall29 reports
- Interject M00518250Boston Scientific Corporation · Biopsy needle70 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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