Single Use Aspiration Needle NA-201SX-4021 (REF N5432630)Recalls & reported problems
Olympus Medical Systems Corp. · NA-201SX-4021 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
Quick summary
This Olympus single-use aspiration needle is a biopsy needle used during endoscopic procedures. Many of the 126 reports describe needle parts breaking, detaching, or tearing, and some describe pieces coming off inside the patient. The reports include 1 death and 28 injuries. Reports fell to 2 in the last 12 months from 45 in the previous 12. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 126
- Deaths reported
- 1
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 04953170389917), received between Oct 1, 2019 and Dec 11, 2025 — classified as 1 death, 28 injuries, 97 malfunctions.
The most frequently reported specific device problem is “Break” (24 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
- Break24
- Detachment of Device or Device Component20
- Material Split, Cut or Torn19
- Mechanical Problem9
- Material Perforation7
- Difficult to Insert5
- Material Puncture/Hole5
- Physical Resistance/Sticking5
Patient problems
- No Clinical Signs, Symptoms or Conditions105
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Foreign Body In Patient6
- Unspecified Infection4
- Air Embolism2
- Fever2
- Fibrosis2
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778290 ↗MalfunctionDec 2, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE EXPERIENCED LEAKING AT THE END OF THE PROCEDURE. THE ISSUE OCCURRED DURING A FIBROSCOPY / ECHO ENDOSCOPY PROCEDURE THAT WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700874 ↗MalfunctionOct 24, 2025Peeled/Delaminated; Peeled/Delaminated
NO NEW ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23381107 ↗MalfunctionOct 24, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THE SINGLE-USE ASPIRATION NEEDLE'S SHEATH/METAL COIL WRAP LOOKED DAMAGED AND BENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379865 ↗InjuryOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A BRONCHOSCOPY PROCEDURE THE DOCTOR WAS GETTING SAMPLES, AND A SECOND DOCTOR WAS ASKED TO ASSIST WITH THE CASE TO SEE IF THEY COULD GET BETTER SAMPLES. AFTER THE LINEAR PORTION WAS FINISHED. THE FIRST DOCTOR WENT BACK IN TO GET A BRUSHING OF THE LUNG WALL WHEN THEY NOTICED METAL IN THE PATIENT'S AIRWAY. UPON LOOKING AT THE NEEDLE, IT WAS NOTED THE TOP SHEATH/COILED SPRING PART WAS MISSING. THE PIECE WAS EXTRACTED. THE PROCEDURE LASTED LONGER THAN EXPECTED DUE TO THE EXTRACTION OF THE NEEDLE PIECE BY ONLY ABOUT FIVE MINUTES. THE EVENT WAS NOTICED AT THE END OF THE PROCEDURE. THE PATIENT WAS UNDER MODERATE SEDATION DURING THE EVENT. THE CUSTOMER INDICATED THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23284692 ↗InjuryOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A BRONCHOSCOPY PROCEDURE THE DOCTOR WAS GETTING SAMPLES, AND A SECOND DOCTOR WAS ASKED TO ASSIST WITH THE CASE TO SEE IF THEY COULD GET BETTER SAMPLES. AFTER THE LINEAR PORTION WAS FINISHED. THE FIRST DOCTOR WENT BACK IN TO GET A BRUSHING OF THE LUNG WALL WHEN THEY NOTICED METAL IN THE PATIENT'S AIRWAY. UPON LOOKING AT THE NEEDLE, IT WAS NOTED THE TOP SHEATH/COILED SPRING PART WAS MISSING. THE PIECE WAS EXTRACTED. THE PROCEDURE LASTED LONGER THAN EXPECTED DUE TO THE EXTRACTION OF THE NEEDLE PIECE BY ONLY ABOUT FIVE MINUTES. THE EVENT WAS NOTICED AT THE END OF THE PROCEDURE. THE PATIENT WAS UNDER MODERATE SEDATION DURING THE EVENT. THE CUSTOMER INDICATED THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23284666 ↗MalfunctionSep 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SINGLE-USE ASPIRATION NEEDLE APPEARED TO HAVE PUNCTURED THE SIDE OF THE PROTECTIVE SHEATH. THIS EVENT WAS REPORTED TO HAVE OCCURRED DURING AN UNSPECIFIED PROCEDURE,. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001291 ↗MalfunctionAug 25, 2025Output Problem; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22883795 ↗MalfunctionAug 8, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE AFTER REMOVAL FROM THE PACKAGING, THE PLASTIC SLEEVES SURROUNDING THE NEEDLE WAS FOUND TO BE CRACKED. THE ISSUE OCCURRED INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751882 ↗MalfunctionAug 8, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE AFTER REMOVAL FROM THE PACKAGING, THE PLASTIC SLEEVES SURROUNDING THE NEEDLE WAS FOUND TO BE CRACKED. THE ISSUE OCCURRED INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751860 ↗MalfunctionAug 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22700250 ↗MalfunctionAug 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THE ASPIRATION NEEDLE BROKE OFF THE WHITE STYLET HANDLE AND SNAPPED OFF THE STYLET WIRE. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE (ENDOBRONCHIAL ULTRASOUND), THERE WAS A REPORTED DELAY AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22700143 ↗MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY, A SINGLE USE ASPIRATION NEEDLE EXPERIENCED A MECHANICAL FAILURE. THE NEEDLE DETACHED FROM BOTH THE WHITE STYLET HANDLE AND THE STYLET WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE INCIDENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22649743 ↗MalfunctionJul 7, 2025Fracture; Fracture
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE SHEATH FLARED AWAY. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22410874 ↗MalfunctionJun 30, 2025Device Handling Problem; Device Handling Problem
IT WAS REPORTED THE SUBJECT DEVICE LOCKING MECHANISM OF THE NEEDLE DID NOT LOCK. THIS ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22367207 ↗MalfunctionJun 30, 2025Device Handling Problem; Device Handling Problem
IT WAS REPORTED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, THE LOCKING MECHANISM OF THE SUBJECT DEVICE WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357180 ↗MalfunctionJun 27, 2025Break; Break
NO NEW ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345579 ↗MalfunctionJun 25, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE NEEDLE OF THE SUBJECT DEVICE WAS NOT ABLE TO LOCK ONTO SCOPE. THE LOCKING MECHANISM WAS WORKING OUT OF THE SCOPE, HOWEVER, WHEN IT WAS ATTEMPTED TO LOCK IT ONTO THE SCOPE, IT WOULD NOT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22327204 ↗MalfunctionJun 13, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT AFTER THE FIRST PUNCTURE OF AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE SUBJECT DEVICE FELT RESISTANCE WHEN THE USER TRIED TO PUNCTURE AGAIN. THE PROCEDURE WAS COMPLETED BY REPLACING WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22207012 ↗MalfunctionJun 10, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE HAD A PUNCTURE IN THE SHEATH. THE ISSUE OCCURRED DURING SEDATION WHILE DEVICE WAS INSIDE THE PATIENT FOR AN ENDOBRONCHIAL ULTRASOUND DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22179082 ↗MalfunctionJun 5, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE WAS NOT LOCKING WHEN IT WAS INSIDE THE PATIENT AND BECAME STUCK AND WOULDN'T MOVE. THE ISSUE OCCURRED DURING SEDATION WHILE DEVICE WAS INSIDE THE PATIENT FOR AN ENDOBRONCHIAL ULTRASOUND PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE WITH DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22152318 ↗MalfunctionJun 3, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THE SUBJECT DEVICE DISCOVERED AN INSECT INSIDE THE NON-STERILE PLASTIC COVER OF THE NEEDLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22132315 ↗MalfunctionMay 29, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107861 ↗MalfunctionMay 23, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE'S LOCKING MECHANISM BROKE AND SNAPPED OFF ON THE SECOND PASS. THE ISSUE OCCURRED DURING A THERAPEUTIC LINEAR ENDOBRONCHIAL ULTRASOUND PROCEDURE AND WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22078002 ↗MalfunctionMay 6, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED; THE SUBJECT DEVICE SHEATH WOULD NOT LOCK CORRECTLY AND STAY IN PLACE. THE ISSUE WAS FOUND DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE DURING SEDATION WITH DEVICE INSIDE PATIENT AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS LESS THAN 30MIN DELAY. NO PATIENT HARM WAS REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21968362 ↗
Other Biopsy needle devices
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- Single Use Aspiration Needle NA-U401SX NA-U401SX-4021Olympus Medical Systems Corp. · Biopsy needle1 recall94 reports
- EchoTip G31520Cook Ireland Ltd · Biopsy needle1 recall84 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
- EchoTip G52012Cook Ireland Ltd · Biopsy needle1 recall18 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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