SINGLE USE ASPIRATION NEEDLE NA-200H-8022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170169977), received between Mar 8, 2023 and Mar 8, 2023 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K023272); 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "A DECADE'S EXPERIENCE OF MANAGING SUSPECTED PANCREATIC ADENOCARCINOMA AT A TERTIARY CANCER CENTER." BACKGROUND: WE PRESENT OUR EXPERIENCE AND ESTABLISHED MANAGEMENT STRATEGY FOR ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE-NEEDLE ASPIRATION (EUS-FNA) IN DIAGNOSING SUSPECTED PANCREATIC NEOPLASMS AT A TERTIARY REFERRAL CANCER HOSPITAL. METHOD: RELEVANT DATA WERE EXTRACTED FROM OUR DATABASE FOR PATIENTS WHO UNDERWENT EUS-FNA FOR SUSPECTED PANCREATIC NEOPLASMS AT OUR INSTITUTION BETWEEN 2007 AND 2016. RESULTS: AMONG THE 309 PATIENTS, THE MEDIAN AGE WAS 67 YEARS AND 56% WERE MEN. THE MOST COMMON PRESENTING SYMPTOMS WERE ABDOMINAL PAIN (37%) AND JAUNDICE (29%). CONCORDANCE BETWEEN RADIOGRAPHIC DIAGNOSIS AND FINAL PATHOLOGY WAS 89%. THE MEAN LESION SIZE WAS 34.9 MM ON COMPUTED TOMOGRAPHY AND 31.5 MM ON EUS. THERE WERE 197 PATIENTS (64%) WITH LOCALIZED DISEASE, OF WHOM 115 (58%) HAD RESECTABLE LESIONS, 61 (31%) HAD BORDERLINE RESECTABLE, AND 21 (11%) HAD UNRESECTABLE LESIONS (MEAN CA 19-9 LEVELS 1705 U/ML, 2490 U/ML, AND 479 U/ML, RESPECTIVELY). A MEDIAN OF 3 FNA PASSES WERE PERFORMED TO ESTABLISH A PATHOLOGIC DIAGNOSIS. TWO PATIENTS (1%) HAD PO

  Patient problems: Pancreatitis

  MAUDE report 16508235 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "A DECADE'S EXPERIENCE OF MANAGING SUSPECTED PANCREATIC ADENOCARCINOMA AT A TERTIARY CANCER CENTER". BACKGROUND WE PRESENT OUR EXPERIENCE AND ESTABLISHED MANAGEMENT STRATEGY FOR ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE-NEEDLE ASPIRATION (EUS-FNA) IN DIAGNOSING SUSPECTED PANCREATIC NEOPLASMS AT A TERTIARY REFERRAL CANCER HOSPITAL. METHOD RELEVANT DATA WERE EXTRACTED FROM OUR DATABASE FOR PATIENTS WHO UNDERWENT EUS-FNA FOR SUSPECTED PANCREATIC NEOPLASMS AT OUR INSTITUTION BETWEEN 2007 AND 2016. RESULTS AMONG THE 309 PATIENTS, THE MEDIAN AGE WAS 67 YEARS AND (B)(4) WERE MEN. THE MOST COMMON PRESENTING SYMPTOMS WERE ABDOMINAL PAIN (B)(4) AND JAUNDICE (B)(4). CONCORDANCE BETWEEN RADIOGRAPHIC DIAGNOSIS AND FINAL PATHOLOGY WAS 89%. THE MEAN LESION SIZE WAS 34.9 MM ON COMPUTED TOMOGRAPHY AND 31.5 MM ON EUS. THERE WERE 197 PATIENTS (B)(4) WITH LOCALIZED DISEASE, OF WHOM 115 (B)(4) HAD RESECTABLE LESIONS, 61 (B)(4) HAD BORDERLINE RESECTABLE, AND 21 (B)(4) HAD UNRESECTABLE LESIONS (MEAN CA 19-9 LEVELS 1705 U/ML, 2490 U/ML, AND 479 U/ML, RESPECTIVELY). A MEDIAN OF 3 FNA PASSES WERE PERFORMED TO ESTABLISH A PATHOLOGIC DIAGNOSIS. TWO PATIENTS (B)(4

  Patient problems: Abdominal Pain; Nausea; Pancreatitis; Vomiting

  MAUDE report 16508121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023272. One submission often covers many models, so check the product and lot details in each record.

• Z-1069-2021 · Jan 4, 2021 · Terminated
  NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and ex