Single Use Aspiration Needle NA-U201H NA-U201H-8019Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Aspiration Needle NA-U201H · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170402548), received between Mar 22, 2024 and Mar 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A THERAPEUTIC ABSCESS DRAINAGE PROCEDURE OF THE PANCREAS AS WELL AS PLACEMENT OF DOUBLE PIGTAILS, THE NEEDLE BROKE IN TWO PLACES. FOUR CENTIMETERS OF THE NEEDLE BROKE OFF AND WAS STUCK IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND NEEDLE. THE ATTENDING PHYSICIAN IS CONSIDERING ATTEMPTING TO RECOVER THE NEEDLE WITH GRASPING FORCEPS OR PE FORCEPS, BUT UPON FOLLOW UP, THERE WAS NO INDICATION THIS HAD HAPPENED YET. WHILE THE NEEDLE WAS STUCK IN THE ABSCESS, THERE WAS NO HEALTH IMPAIRMENT ACCORDING TO THE ATTENDING PHYSICIAN AND THE AIM OF THE PROCEDURE WAS ACHIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 18959623 ↗
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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