Worley Advanced CSG 00884450484319Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450484319), received between Aug 1, 2023 and Aug 1, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 11, 2024Class IIOpen, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2577-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN UPGRADE TO A BIV-ICD PROCEDURE WHEN SPLITTING THE PEEL-AWAY SHEATH, THE RADIOPAQUE MARKER BAND DETACHED AND MIGRATED TO THE PATIENT'S LUNG. THE PHYSICIAN STATES THAT NO UNUSUAL ANATOMY WAS NOTED DURING THE PROCEDURE FOR THIS PATIENT, AND NO HEMODYNAMIC CHANGES DUE TO THE FOREIGN BODY INTRODUCTION WERE NOTED. THE PATIENT IS DOING WELL, THERE ARE NO PLANS TO REMOVE THE FOREIGN BODY FROM THIS PATIENT. ADMISSION TO THE HOSPITAL OR PROLONGATION OF HOSPITALIZATION WAS NOT NECESSARY. NO ADDITIONAL INTERVENTIONS OR MEDICATION WERE NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17438374 ↗