Single Use Aspiration Needle NA-U200H NA-U200H-8019SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170380440), received between Aug 25, 2022 and Jan 19, 2023 — classified as 1 death, 3 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED, "ENDOSCOPIC ULTRASOUND-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT CORRELATES WITH HISTOLOGICAL HEPATIC FIBROSIS." BACKGROUND AND AIMS: ENDOSCOPIC ULTRASOUND IS A NOVEL DIAGNOSTIC APPROACH TO CHRONIC LIVER DISEASES (CLDS), AND EUS-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT (EUS-PPG) IS AN IMPORTANT EXPANSION WITH A WELL-DEVELOPED TECHNIQUE. HOWEVER, THE CLINICAL VALUE AND APPLICABILITY OF EUS-PPG MEASUREMENT IN PREDICTING HISTOLOGICALLY ADVANCED HEPATIC FIBROSIS REMAIN UNKNOWN. METHODS: THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY ON PATIENTS WITH VARIOUS CLDS UNDERGOING EUS-PPG AND EUS-GUIDED LIVER BIOPSY (EUS-BX) TO ASSESS IF EUS-PPG MEASUREMENTS CORRELATE WITH HISTOLOGICAL FIBROSIS STAGE AND VARIOUS SURROGATE MARKERS FOR SEVERITY OF CLDS AND ITS SAFETY. CASES WITH EUS-PPG WERE IDENTIFIED AT THE UNIVERSITY OF CALIFORNIA IRVINE, A TERTIARY ENDOSCOPY CENTER, BETWEEN JANUARY 2014 AND MARCH 2020. RESULTS: IN 64 PATIENTS, THE MEAN AGE WAS 57.5; 40 (62.5%), MALES; MEAN CHILD-TURCOTTE-PUGH (CTP) AND MODEL FOR END-STAGE LIVER DISEASE (MELD) SCORES, 5.9 AND 10.4, RESPECTIVELY. THE PROCEDURE SUCCESS RATE WA

  Patient problems: Biliary Cirrhosis; Thrombocytopenia

  MAUDE report 16210361 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED, "ENDOSCOPIC ULTRASOUND-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT CORRELATES WITH HISTOLOGICAL HEPATIC FIBROSIS". BACKGROUND AND AIMS ENDOSCOPIC ULTRASOUND IS A NOVEL DIAGNOSTIC APPROACH TO CHRONIC LIVER DISEASES (CLDS), AND EUS-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT (EUS-PPG) IS AN IMPORTANT EXPANSION WITH A WELL-DEVELOPED TECHNIQUE. HOWEVER, THE CLINICAL VALUE AND APPLICABILITY OF EUS-PPG MEASUREMENT IN PREDICTING HISTOLOGICALLY ADVANCED HEPATIC FIBROSIS REMAIN UNKNOWN. METHODS THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY ON PATIENTS WITH VARIOUS CLDS UNDERGOING EUS-PPG AND EUS-GUIDED LIVER BIOPSY (EUS-BX) TO ASSESS IF EUS-PPG MEASUREMENTS CORRELATE WITH HISTOLOGICAL FIBROSIS STAGE AND VARIOUS SURROGATE MARKERS FOR SEVERITY OF CLDS AND ITS SAFETY. CASES WITH EUS-PPG WERE IDENTIFIED AT THE UNIVERSITY OF CALIFORNIA IRVINE, A TERTIARY ENDOSCOPY CENTER, BETWEEN JANUARY 2014 AND MARCH 2020. RESULTS IN 64 PATIENTS, THE MEAN AGE WAS 57.5; 40 (62.5%), MALES; MEAN CHILD-TURCOTTE-PUGH (CTP) AND MODEL FOR END-STAGE LIVER DISEASE (MELD) SCORES, 5.9 AND 10.4, RESPECTIVELY. THE PROCEDURE SUCCESS RATE WAS 1

  Patient problems: Biliary Cirrhosis; Thrombocytopenia

  MAUDE report 16207921 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY VERSUS HEPATICOGASTROSTOMY WITH ANTEGRADE STENTING FOR MALIGNANT DISTAL BILIARY OBSTRUCTION." LITERATURE SUMMARY: RECURRENT BILIARY OBSTRUCTION (RBO) IS A POSSIBLE COMPLICATION OF ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION (MDBO). METHODS: WE RETROSPECTIVELY EVALUATED CONSECUTIVE PATIENTS WHO UNDERWENT EUS-HGS OR HGAS . THE TRBO, OVERALL SURVIVAL (OS), AND ADVERSE EVENT (AE) RATE WERE COMPARED BETWEEN THE GROUPS. RESULTS: THIS STUDY INCLUDED 96 PATIENTS (EUS-HGS, N = 58; HGAS, N = 38). THERE WAS A SIGNIFICANT DIFFERENCE IN THE CAUSE OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FAILURE AND THE HGS STENT TYPE BETWEEN THE GROUPS. CONCLUSIONS: ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY PROLONGED THE TRBO COMPARED WITH EUS-HGS FOR BILIARY DRAINAGE IN PATIENTS WITH MDBO. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: RECURRENT BILIARY OBSTRUCTION - 20 PATIENTS. PERITONITIS - 5 PATIENTS. CHOLANGITIS - 2 PATIENTS. PANCREATITIS - 5 PATIENTS. BLEEDING - 2 PATIENTS. DEATH 10 DAYS AFTER ONSET OF SEPTIC SHOCK - 1 PATIENTS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Peritonitis; Pseudoaneurysm; Unspecified Hepatic or Biliary Problem

  MAUDE report 15294385 ↗
• DeathAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY VERSUS HEPATICOGASTROSTOMY WITH ANTEGRADE STENTING FOR MALIGNANT DISTAL BILIARY OBSTRUCTION." LITERATURE SUMMARY: RECURRENT BILIARY OBSTRUCTION (RBO) IS A POSSIBLE COMPLICATION OF ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION (MDBO). METHODS: WE RETROSPECTIVELY EVALUATED CONSECUTIVE PATIENTS WHO UNDERWENT EUS-HGS OR HGAS . THE TRBO, OVERALL SURVIVAL (OS), AND ADVERSE EVENT (AE) RATE WERE COMPARED BETWEEN THE GROUPS. RESULTS: THIS STUDY INCLUDED 96 PATIENTS (EUS-HGS, N = 58; HGAS, N = 38). THERE WAS A SIGNIFICANT DIFFERENCE IN THE CAUSE OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FAILURE AND THE HGS STENT TYPE BETWEEN THE GROUPS. CONCLUSIONS: ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY PROLONGED THE TRBO COMPARED WITH EUS-HGS FOR BILIARY DRAINAGE IN PATIENTS WITH MDBO. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: RECURRENT BILIARY OBSTRUCTION - 20 PATIENTS. PERITONITIS - 5 PATIENTS. CHOLANGITIS - 2 PATIENTS. PANCREATITIS - 5 PATIENTS. BLEEDING - 2 PATIENTS. DEATH 10 DAYS AFTER ONSET OF SEPTIC SHOCK - 1 PATIENTS

  Patient problems: Septic Shock

  MAUDE report 15294373 ↗