Single Use Aspiration Needle NA-U401SX-4025N (UDI 04953170402005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170402005), received between Jun 1, 2022 and Aug 26, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461138 ↗
• MalfunctionDec 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE ASPIRATION NEEDLE'S PROXIMAL ATTACHMENT OF THE MANDREL ON THE FELL OFF. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896452 ↗
• MalfunctionAug 18, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833085 ↗
• InjuryMar 24, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UNKNOWN PROCEDURE, THIS SINGLE USE ASPIRATION NEEDLE BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS DELAYED WITH PATIENT UNDER ANESTHESIA, HOWEVER, THE AMOUNT OF TIME IS UNKNOWN. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611756 ↗
• InjuryMar 24, 2023Break; Break

  THIS REPORT IS SUBMITTED TO UPDATE FIELD D4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610689 ↗
• InjuryFeb 8, 2023Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED ENDOSCOPIC PROCEDURE, WHERE THE PATIENT¿S ESOPHAGUS WAS TO BLOCKED AND INJECTED WITH STEROIDS AS AN ADDITIONAL TREATMENT, THE SLEEVE OF THE NEEDLE HAD LOST CONTACT WITH THE END OF THE ASPIRATION NEEDLE WHILE INSIDE THE LYMPH NODE. THE NEEDLE WAS NOT ABLE TO BE WITHDRAWN WITHOUT REMOVING THE ENTIRE NEEDLE HOLDER, THEREFORE, THE NEEDLE WAS CUT AT THE AND THE NEEDLE AND THE SCOPE WERE THEN WITHDRAWN SIMULTANEOUSLY. THE PROCEDURE WAS ABORTED INTRAOPERATIVELY. THIS COMPLAINT REQUIRED TWO REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): NA-U401-SX4025N. (B)(6): BF-UC190F. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329103 ↗
• InjuryJun 1, 2022Separation Problem; Separation Problem

  THE CUSTOMER REPORTED TO OLYMPUS, DURING AN UNSPECIFIED PROCEDURE, THE UNKNOWN VIZISHOT2 NEEDLE CAME OUT OF THE CATHETER/SHEATH AND WOULD NOT GO BACK IN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE NEEDLE FROM THE PATIENT ALTHOUGH THE PATIENT'S AIRWAY WAS SCRATCHED WHILE REMOVING THE NEEDED. THE NEEDLE WAS EXTENDED INTO THE LYMPH NODE. SINCE THE PHYSICIAN WAS UNABLE TO PULL THE NEEDLE BACK, THE ENTIRE ENDOSCOPE WAS REMOVED FROM THE PATIENT WITH THE NEEDLE STICKING OUT IN ORDER TO RETRIEVE IT. THERE WAS MINOR INJURY TO THE PATIENT AS THE NEEDLE WAS TAKEN OUT OF PATIENT, BUT THERE WAS NO SUSTAINED BLEEDING AFTERWARDS NOTED AND NO OTHER IMMEDIATE INJURY. MODEL NA-U401SX-4025N WAS SELECTED AS A REPRESENTATIVE FOR THE REPORTED DEVICE: VIZISHOT 2.

  Patient problems: Foreign Body In Patient

  MAUDE report 14565690 ↗
• InjuryJun 1, 2022Device Dislodged or Dislocated

  THE CUSTOMER REPORTED TO OLYMPUS, DURING AN UNSPECIFIED PROCEDURE, THE UNKNOWN VIZISHOT2 NEEDLE CAME OUT OF THE CATHETER/SHEATH AND WOULD NOT GO BACK IN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE NEEDLE FROM THE PATIENT ALTHOUGH THE PATIENT'S AIRWAY WAS SCRATCHED WHILE REMOVING THE NEEDED. THE NEEDLE WAS EXTENDED INTO THE LYMPH NODE. SINCE THE PHYSICIAN WAS UNABLE TO PULL THE NEEDLE BACK, THE ENTIRE ENDOSCOPE WAS REMOVED FROM THE PATIENT WITH THE NEEDLE STICKING OUT IN ORDER TO RETRIEVE IT. THERE WAS MINOR INJURY TO THE PATIENT AS THE NEEDLE WAS TAKEN OUT OF PATIENT, BUT THERE WAS NO SUSTAINED BLEEDING AFTERWARDS NOTED AND NO OTHER IMMEDIATE INJURY. MODEL NA-U401SX-4025N WAS SELECTED AS A REPRESENTATIVE FOR THE REPORTED DEVICE: VIZISHOT 2.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14565679 ↗