UltraCore™ Biopsy Needle 762618160Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886333006427), received between Oct 8, 2024 and Dec 12, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT PERCUTANEOUS LUNG BIOPSY IN THE CT ROOM OF THE RADIOTHERAPY DEPARTMENT. POSTOPERATIVE CT IMAGES SHOWED THAT THE PATIENT DEVELOPED A SMALL AMOUNT OF PNEUMOTHORAX. FIVE MINUTES LATER, A CHEST X-RAY CT SCAN WAS PERFORMED, AND THE CT IMAGE SHOWED NO SIGNIFICANT CHANGES IN PNEUMOTHORAX. AFTER THE SURGERY, THE PATIENT RETURNED TO THE WARD SAFELY. THE HOSPITAL REPORTED THIS CASE TO NMPA.

  Patient problems: Pneumothorax

  MAUDE report 20915713 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED "THE PATIENT IS EXPERIENCING BLEEDING AND PNEUMOTHORAX."

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 20913907 ↗
• MalfunctionNov 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT UNDERWENT CT GUIDED BIOPSY OF A SPACE OCCUPYING LESION IN THE UPPER LOBE OF THE RIGHT LUNG IN THE CT ROOM OF THE RADIOTHERAPY DEPARTMENT. A TOTAL OF 3 GRAY RED AND GRAY BLACK TISSUES WERE OBTAINED, SOME OF WHICH WERE FRAGMENTED AND HAD A SIZE OF APPROXIMATELY 0.5-1.0 × 0.1CM. THE SPECIMENS WERE FIXED IN 10% FORMALIN SOLUTION AND SENT TO THE PATHOLOGY DEPARTMENT FOR CYTOLOGICAL EXAMINATION. THE COAXIAL PUNCTURE NEEDLE WAS REMOVED AND THE PUNCTURE SITE WAS WRAPPED AND FIXED. CT RE EXAMINATION SHOWED NO EXUDATION IN THE PUNCTURE SITE, MODERATE PNEUMOTHORAX ON THE RIGHT SIDE, AND NO PLEURAL EFFUSION.

  Patient problems: Pneumothorax

  MAUDE report 20652851 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT CT GUIDED BIOPSY OF A SPACE OCCUPYING LESION IN THE UPPER LOBE OF THE RIGHT LUNG IN THE CT ROOM OF THE RADIOTHERAPY DEPARTMENT. A TOTAL OF 3 GRAY RED AND GRAY BLACK TISSUES WERE OBTAINED, SOME OF WHICH WERE FRAGMENTED AND HAD A SIZE OF APPROXIMATELY 0.5-1.0 × 0.1CM. THE SPECIMENS WERE FIXED IN 10% FORMALIN SOLUTION AND SENT TO THE PATHOLOGY DEPARTMENT FOR CYTOLOGICAL EXAMINATION. THE COAXIAL PUNCTURE NEEDLE WAS REMOVED AND THE PUNCTURE SITE WAS WRAPPED AND FIXED. CT RE EXAMINATION SHOWED NO EXUDATION IN THE PUNCTURE SITE, MODERATE PNEUMOTHORAX ON THE RIGHT SIDE, AND NO PLEURAL EFFUSION.

  Patient problems: Pneumothorax

  MAUDE report 20550093 ↗
• MalfunctionOct 8, 2024Failure to Obtain Sample; Failure to Obtain Sample

  PERCUTANEOUS LUNG BIOPSY WAS PERFORMED IN THE CT ROOM OF THE RADIOTHERAPY DEPARTMENT. POSTOPERATIVE CT IMAGES SHOWED THAT THE PATIENT DEVELOPED A SMALL AMOUNT OF PNEUMOTHORAX. FIVE MINUTES LATER, A CHEST CT SCAN WAS PERFORMED, AND THE CT IMAGES SHOWED NO SIGNIFICANT CHANGES IN PNEUMOTHORAX. AFTER THE SURGERY, THE PATIENT RETURNED TO THE WARD SAFELY. THE SAMPLE COULD NOT BE TAKEN OUT.

  Patient problems: Pneumothorax

  MAUDE report 20397378 ↗