Single Use Aspiration Needle NA-201SX-4022 (REF N5432430)Recalls & reported problems
Olympus Medical Systems Corp. · NA-201SX-4022 Single Use Aspiration Needle · Class 2
All models of Single Use Aspiration Needle (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170389894), received between Nov 28, 2018 and Jun 30, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2019Break; Break
DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE NEEDLE BROKE OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FALLING OF THE NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8746926 ↗MalfunctionNov 28, 2018Break; Break
DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION, THE SUBJECT DEVICE WAS USED. THE NEEDLE TUBE OF THE SUBJECT DEVICE COULD NOT BE RETRACTED INTO THE SHEATH. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FAILURE OF RETRACTING THE NEEDLE TUBE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8113912 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page