Single Use Aspiration Needle NA-U401SX NA-U401SX-4021 (REF R5000691)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of Single Use Aspiration Needle NA-U401SX (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus single-use aspiration needle is used to take samples through a needle during endobronchial ultrasound procedures. Reports mostly describe the needle's sheath splitting, tearing, puncturing or breaking during use, with fragments sometimes left behind, and procedures that had to be delayed or finished with a backup device. There are 57 reports, no deaths and 2 injuries, and 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
- 51
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 04953170409974), received between Aug 9, 2024 and Sep 18, 2026 — classified as 2 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (10 reports).
2 other recalls cover devices cleared under the same FDA submission (K160098); they may or may not involve this specific model.
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
- Material Split, Cut or Torn10
- Break8
- Material Integrity Problem6
- Material Puncture/Hole5
- Material Twisted/Bent4
- Mechanical Problem3
- Activation Failure2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
Sheath of needle broke.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818354 ↗MalfunctionAug 24, 2026Material Frayed; Difficult to Advance; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410655 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE DETACHED WHEN PULLING THE NEEDLE BACK UP THROUGH THE SCOPE. THE ISSUE OCCURRED DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION AND THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886190 ↗MalfunctionFeb 25, 2026Material Twisted/Bent
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE, HAD A 90-DEGREE BEND IN THE BLADE AND DAMAGE TO THE SHEATH. IN ADDITION, THE DAMAGED NEEDLE HAD PIERCED THE WORKING CHANNEL OF THE BRONCHOSCOPE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND (EBUS) -GUIDED TRANSBRONCHIAL MEDIASTINAL BIOPSY THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443636 ↗MalfunctionFeb 11, 2026Material Puncture/Hole
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE PUNCTURED THE SCOPE. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND AND WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314104 ↗MalfunctionJan 30, 2026Material Puncture/Hole
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE DEPLOYED THROUGH THE SHEATH. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223815 ↗MalfunctionJan 16, 2026Material Puncture/Hole
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24097043 ↗InjuryJan 6, 2026Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23982174 ↗MalfunctionDec 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23897724 ↗MalfunctionDec 16, 2025Unintended Movement; Unintended Movement
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23818366 ↗MalfunctionDec 10, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE¿S SHEATH WAS DAMAGED. THE ISSUE WAS FOUND AFTER AN UNSPECIFIED ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772276 ↗MalfunctionDec 10, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE¿S SHEATH WAS DAMAGED. THE ISSUE WAS FOUND AFTER AN UNSPECIFIED ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772212 ↗MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708901 ↗MalfunctionDec 1, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THE SINGLE-USE ASPIRATION NEEDLE'S SHEATH WAS NOT COMING OUT CORRECTLY. IT WAS FURTHER STATED THAT THE SHEATH FRAYED WHEN PUSHING THE NEEDLE THROUGH. THIS EVENT OCCURRED DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23684762 ↗MalfunctionNov 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23644677 ↗MalfunctionNov 20, 2025Obstruction of Flow; Obstruction of Flow
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 23606113 ↗MalfunctionNov 19, 2025Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595434 ↗MalfunctionNov 12, 2025Mechanical Problem; Mechanical Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23539344 ↗MalfunctionNov 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE TIP OF THE SHEATH ON THE ASPIRATION NEEDLE IS BEING SHORN/SPLIT WHEN PASSING THE NEEDLE THROUGH. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC LINEAR ENDOBRONCHIAL ULTRASOUND (EBUS), WHICH WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496773 ↗MalfunctionNov 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496772 ↗MalfunctionOct 30, 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 23430183 ↗MalfunctionOct 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23429868 ↗MalfunctionOct 30, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE ASPIRATION NEEDLE HAD PUNCTURED THROUGH ITS SHEATH. THE REPORTED ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS), WHICH WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423636 ↗MalfunctionOct 24, 2025Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23384259 ↗MalfunctionSep 19, 2025Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095053 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K160098. One submission often covers many models, so check the product and lot details in each record.
- Z-1616-2023 · Mar 31, 2023 · Open, ClassifiedTo be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal
- Z-1615-2023 · Mar 31, 2023 · Open, ClassifiedViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the t
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