Single Use Injector NM-400L-0423 (UDI 04953170259739)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170259739), received between Feb 17, 2020 and Oct 15, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR.

  Patient problems: Abdominal Pain; Blood Protein Abnormal; Fever; High White Blood Cell Count; Pneumoperitoneum; Unspecified Infection

  MAUDE report 23299388 ↗
• InjuryFeb 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿NEUROLOGICAL SYMPTOMS AND SPINAL CORD EMBOLISM CAUSED BY ENDOSCOPIC INJECTION SCLEROTHERAPY FOR ESOPHAGEAL VARICES¿. THE FOLLOWING IS A SUMMARY OF THE LITERATURE: THE PATIENT WHO HAD (B)(6) HAD THE LIGATION TREATMENT OF ESOPHAGEAL AND GASTRIC VARICES WITH TISSUE GLUE INJECTION UNDER INTRAVENOUS ANESTHESIA. OLYMPUS SINGLE USE INJECTOR MODEL NM-400L-0423 AND GASTROINTESTINAL VIDEOSCOPE MODEL GIF-Q260J WERE USED FOR THE PROCEDURES. THE PROCEDURE WAS COMPLETED AND THE PATIENT RETURNED TO THE HOSPITAL WARD. SIX HOURS AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF THE WEAKNESS AND NUMBNESS IN THE LOWER LIMBS, ABDOMINAL DISTENSION AND SLIGHT DYSURESIA. THE PATIENT'S VITAL SIGNS WERE STABLE, LOWER EXTREMITIES WERE NORMAL, THE RIGHT LIMB MUSCLE STRENGTH WAS IV LEVEL, AND BILATERAL BABINSKI SIGNS WERE POSITIVE. THE PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) OF THE THORACIC AND LUMBAR SPINE WITHIN TWELVE HOURS POSTOPERATION AND SPINAL CORD EMBOLISM WAS DETECTED. THEREFORE, THE FACILITY STOPPED THE HEMOSTATIC AND COAGULATION REGIMEN IMMEDIATELY AND STARTED NERVE NOURISHMENT AND MICROCIRCULATION THERAPIES, ALONG WITH DEXAMETHA

  Patient problems: Embolism

  MAUDE report 9716150 ↗