Co-Axial Introducer Needle MCXS1815BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333002405), received between Dec 1, 2023 and Sep 17, 2024 — classified as 1 injury, 1 malfunction.

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.

• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED "THE PATIENT UNDERWENT CT GUIDED RIGHT LUNG BIOPSY SURGERY, AND 3 BIOPSIES WERE TAKEN. THE PATIENT DEVELOPED HEMOPTYSIS, AND CT RE EXAMINATION SHOWED SIGNIFICANT PNEUMOTHORAX."

  Patient problems: Hemoptysis; Pneumothorax

  MAUDE report 20241166 ↗
• MalfunctionDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A PUNCTURE BIOPSY OF THE LEFT LUNG MASS. AFTER THE SURGERY, THE PATIENT'S VITAL SIGNS WERE STABLE AND THEY FELT A SLIGHT SUFFOCATION. THE NEXT DAY, A CHEST X-RAY WAS REVIEWED TO REPORT LEFT PNEUMOTHORAX, AND THE PATIENT AND THEIR FAMILY MEMBERS WERE COMMUNICATED ABOUT THE CONDITION. IF THE PATIENT EXPERIENCED COMPLICATIONS AFTER THE PUNCTURE SURGERY, A CLOSED THORACIC DRAINAGE SURGERY WAS PERFORMED, AND THE PATIENT'S SUFFOCATION SYMPTOMS WERE RELIEVED AFTER THE SURGERY.

  Patient problems: Pneumothorax

  MAUDE report 18253172 ↗