Single Use Aspiration Needle NA-U200HRecalls & reported problems across all models

We found 5 models of Single Use Aspiration Needle NA-U200H by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Jan 11, 2022 and Dec 18, 2025 — classified as 3 deaths, 30 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Single Use Aspiration Needle NA-U200H problems

Single Use Aspiration Needle NA-U200H models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Single Use Aspiration Needle NA-U200H NA-U200H-8019

  Biopsy needle
  2 deaths28 reports
• Single Use Aspiration Needle NA-U200H NA-U200H-8022

  Biopsy needle
  17 reports
• Single Use Aspiration Needle NA-U200H NA-U200H-8019S

  Biopsy needle
  1 death4 reports
• Single Use Aspiration Needle NA-U200H NA-U200H-8025

  Biopsy needle
  3 reports
• Single Use Aspiration Needle NA-U200H NA-U200H-8022S

  Biopsy needle
  2 reports

Recent Single Use Aspiration Needle NA-U200H adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838526 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿TRANSLUMINAL ANTEGRADE DRILL DILATION TECHNIQUE FOR HEPATICOJEJUNOSTOMY STRICTURE WITH CHOLANGIOSCOPIC EVALUATION (WITH VIDEO)¿. BACKGROUND AND STUDY AIMS : BALLOON DILATION AND PLASTIC STENT DEPLOYMENT HAVE BEEN PERFORMED AS HEPATICOJEJUNOSTOMY STRICTURE (HJS) TREATMENT TECHNIQUES UNDER ENDOSCOPIC ULTRASOUND GUIDANCE (EUS). ALTHOUGH THESE TECHNIQUES HAVE SHOWN FAVORABLE CLINICAL RESULTS, THE TREATMENT PERIOD CAN BE LONG BECAUSE STENT DEPLOYMENT IS REQUIRED. IN ADDITION, HJS MAY RECUR EVEN AFTER TREATMENT BECAUSE THE SCAR TISSUE ITSELF REMAINS. TO OVERCOME THESE CHALLENGES, WE DEVELOPED AN EUS-GUIDED ANTEGRADE DRILL DILATION TECHNIQUE FOR TREATING HJS. THE AIM OF THIS STUDY WAS TO EVALUATE THE TECHNICAL FEASIBILITY AND SAFETY OF THIS TECHNIQUE IN TERMS OF THE PRE- AND POST-CHOLANGIOSCOPIC FINDINGS. METHODS: THIS RETROSPECTIVE STUDY INCLUDED CONSECUTIVE PATIENTS WHOSE CONDITIONS WERE COMPLICATED WITH SYMPTOMATIC HJS BETWEEN NOVEMBER 2022 AND FEBRUARY 2023. TRANSLUMINAL ANTEGRADE DRILL DILATION (TAD) USING A NOVEL DRILL DILATOR WAS ATTEMPTED WITHIN 14 DAYS AFTER EUS-GUIDED HEPATICOGASTROSTOMY (HGS). HJS WAS DIAGNOSED WITH CHOLANGIOSCO

  Patient problems: Cholangitis

  MAUDE report 22926525 ↗
• MalfunctionAug 1, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE NA-U200H WAS IMPOSSIBLE TO REMOVE AFTER THE SECOND PASS. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686234 ↗
• MalfunctionJul 21, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE SUBJECT DEVICE WAS USED AFTER THE STERILIZATION HAD EXPIRED. THERE WERE NO REPORTS OF PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556675 ↗
• MalfunctionJun 17, 2025Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THE SUBJECT DEVICE EXPIRATION ON THE BOX STATES 2/28/2025 AND THE EXPIRATION ON DEVICE WAS 4/30/2026. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237871 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR THAT CONFIRMED NO DEVICE MALFUNCTIONED, AND NO DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENTS.

  Patient problems: Peritonitis

  MAUDE report 21576718 ↗
• MalfunctionJan 6, 2025

  OLYMPUS SINGLE USE ASPIRATION NEEDLE WAS BENT UPON REMOVING FROM PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078888 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿COMPARING NEEDLES AND METHODS OF ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY TO OPTIMIZE SPECIMEN QUALITY AND DIAGNOSTIC ACCURACY FOR PATIENTS WITH PANCREATIC MASSES IN A RANDOMIZED TRIAL¿. BACKGROUND & AIMS: GIVEN THE LACK OF PROCEDURE STANDARDIZATION, FINDINGS VARY FROM ANALYSES OF PANCREATIC TISSUES COLLECTED BY ENDOSCOPIC ULTRASOUND¿GUIDED FINE-NEEDLE BIOPSY. IT IS NOT CLEAR WHICH NEEDLE AND TECHNIQUE YIELD THE BEST SPECIMEN FOR ANALYSIS. WE COMPARED THE SPECIMEN QUALITY AND ACCURACY OF DIAGNOSES MADE FROM SAMPLES COLLECTED BY FINE-NEEDLE BIOPSY NEEDLES USING DIFFERENT COLLECTION TECHNIQUES. METHODS: PATIENTS FOUND TO HAVE PANCREATIC MASSES DURING IMAGING (N 129) WERE ASSIGNED RANDOMLY TO GROUPS FROM WHOM PANCREATIC TISSUE SAMPLES WERE COLLECTED BY REVERSE-BEVEL, MENGHINI-TIP, FRANSEEN, OR FORK-TIP NEEDLES. A SECOND RANDOMIZATION DETERMINED THE TECHNICAL SEQUENCE OF BIOPSIES IN EACH PATIENT (SUCTION, NO SUCTION, AND STYLET RETRACTION). TWO INDEPENDENT PATHOLOGISTS, BLINDED TO THE TYPE OF NEEDLE AND SAMPLING TECHNIQUE, ANALYZED ALL THE SAMPLES. FINAL DIAGNOSES OF MALIGNANCY WERE MADE BASED ON SURGICAL RESECTION, DEATH FROM CA

  Patient problems: Abdominal Pain; Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20847547 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿COMPARING NEEDLES AND METHODS OF ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY TO OPTIMIZE SPECIMEN QUALITY AND DIAGNOSTIC ACCURACY FOR PATIENTS WITH PANCREATIC MASSES IN A RANDOMIZED TRIAL¿. BACKGROUND & AIMS: GIVEN THE LACK OF PROCEDURE STANDARDIZATION, FINDINGS VARY FROM ANALYSES OF PANCREATIC TISSUES COLLECTED BY ENDOSCOPIC ULTRASOUND¿GUIDED FINE-NEEDLE BIOPSY. IT IS NOT CLEAR WHICH NEEDLE AND TECHNIQUE YIELD THE BEST SPECIMEN FOR ANALYSIS. WE COMPARED THE SPECIMEN QUALITY AND ACCURACY OF DIAGNOSES MADE FROM SAMPLES COLLECTED BY FINE-NEEDLE BIOPSY NEEDLES USING DIFFERENT COLLECTION TECHNIQUES. METHODS: PATIENTS FOUND TO HAVE PANCREATIC MASSES DURING IMAGING (N 129) WERE ASSIGNED RANDOMLY TO GROUPS FROM WHOM PANCREATIC TISSUE SAMPLES WERE COLLECTED BY REVERSE-BEVEL, MENGHINI-TIP, FRANSEEN, OR FORK-TIP NEEDLES. A SECOND RANDOMIZATION DETERMINED THE TECHNICAL SEQUENCE OF BIOPSIES IN EACH PATIENT (SUCTION, NO SUCTION, AND STYLET RETRACTION). TWO INDEPENDENT PATHOLOGISTS, BLINDED TO THE TYPE OF NEEDLE AND SAMPLING TECHNIQUE, ANALYZED ALL THE SAMPLES. FINAL DIAGNOSES OF MALIGNANCY WERE MADE BASED ON SURGICAL RESECTION, DEATH FROM CA

  Patient problems: Abdominal Pain; Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20846590 ↗
• MalfunctionDec 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE THERAPEUTIC PROCEDURE, THE NEEDLE BROKE OFF AND WAS DISCOVERED ON THE FLOOR. THE NEEDLE WAS DISCARDED AND THE PROCEDURE WAS COMPLETED UTILIZING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833688 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Pancreatitis

  MAUDE report 20737438 ↗
• MalfunctionSep 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE SINGLE USE ASPIRATION NEEDLE BECAME STUCK IN THE SHEATH DURING THE FIRST EXTRACTION. THE ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258513 ↗
• InjuryAug 23, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A PANCREATIC CYST DRAINAGE, THE DEVICE DID NOT COME OUT OF THE SHEATH. DUE TO THIS MALFUNCTION, THE PROCEDURE WAS ABORTED AND IS SCHEDULED TO BE COMPLETED 8AUG2024. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WERE NO HEALTH PROBLEMS FOR THE PATIENT OTHER THAN THE POSTPONEMENT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055563 ↗
• MalfunctionJul 11, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE ASPIRATION NEEDLE GUIDEWIRE WAS DIFFICULT TO INSERT AND GOT STUCK. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724703 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE ARTICLE, "ERCP USING BALLOON-ASSISTED ENDOSCOPES VERSUS EUS-GUIDED TREATMENT FOR COMMON BILE DUCT STONES IN ROUX-EN-Y GASTRECTOMY." CONSECUTIVE PATIENTS WHO HAD PREVIOUS ROUX-EN-Y (R-Y) GASTRECTOMY UNDERGOING BALLOON-ASSISTED ENDOSCOPE (BE-ERCP) OR EUS-GUIDED ANTEGRADE TREATMENT (EUS-AG) FOR COMMON BILE DUCT (CBD) STONES IN 16 CENTERS WERE RETROSPECTIVELY ANALYZED. PATIENTS WHO UNDERWENT ENDOSCOPIC INTERVENTIONS BETWEEN JANUARY 2009 AND MARCH 2020 WERE ENROLLED. BALLOON-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP): TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS PANCREATITIS (23) CHOLANGITIS (7) CHOLECYSTITIS (1) MAJOR OR MINOR PERFORATION (15) LACERATION (3) BLEEDING (3) ASPIRATION PNEUMONIAE (4) RESPIRATORY FAILURE (2) PULMONARY EMBOLISM (1) BRADYCARDIA (1) ENDOSCOPIC ULTRASOUND (EUS)-GUIDED ANTEGRADE TREATMENT: TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS CHOLANGITIS (3) CHOLECYSTITIS (1) BILE PERITONITIS (2) ABDOMINAL PAIN WITH FEVER (5) THE SELECTION OF THE INTERVENTION WAS AT THE DISCRETION OF ENDO- SCOPISTS. WHEN THE INITIAL PROCEDURE FAILED, AN ALTERNATIVE TREATMENT WAS CHOSEN FROM ANOTHER ENDOSCOPIC INTERVENTION, PERCUTANEOUS TRANSHEPATIC BILI

  Patient problems: Abdominal Pain; Aspiration Pneumonitis; Bradycardia; Cholangitis; Fever; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Pancreatitis; Perforation; Peritonitis; Pulmonary Embolism; Respiratory Failure

  MAUDE report 19640041 ↗

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