Single Use Aspiration Needle NA-U201H NA-U201H-8022Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170402586), received between Aug 10, 2022 and Oct 30, 2025 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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
- Detachment of Device or Device Component5
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PLASTIC TUBE OF THE ASPIRATION NEEDLE HAD DETATCHED FROM THE HANDLE. THE REPORTED ISSUE OCCURRED DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION (EUS-FNA) FOR A MALIGNANT LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424117 ↗MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PLASTIC TUBE OF THE ASPIRATION NEEDLE HAD DETACHED FROM THE HANDLE. THE REPORTED ISSUE OCCURRED DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION (EUS-FNA) FOR A MALIGNANT LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424114 ↗MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23396375 ↗MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT PART OF THE PLASTIC SHEATHING OF THE SUBJECT DEVICE CAME OFF. THE PART CAME OFF OUTSIDE OF THE PATIENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15739451 ↗MalfunctionAug 16, 2022Break
SINGLE USE ASPIRATION NEEDLE BROKE OFF IN MASS IN PANCREATIC HEAD DURING FINE NEEDLE BIOPSY. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 15242568 ↗InjuryAug 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A SINGLE USE ASPIRATION NEEDLE, THE NEEDLE BROKE OFF INSIDE THE PATIENT (INSIDE THE TUMOR). IT IS UNKNOWN IF THE NEEDLE WAS SUCCESSFULLY RETRIEVED. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15198996 ↗InjuryAug 10, 2022Break
THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A SINGLE USE ASPIRATION NEEDLE, THE NEEDLE BROKE OFF INSIDE THE PATIENT (INSIDE THE TUMOR). IT IS UNKNOWN IF THE NEEDLE WAS SUCCESSFULLY RETRIEVED. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15198957 ↗
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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