Combined Spinal & Epidural 339114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964940613), received between Jan 16, 2025 and Mar 7, 2025 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Jul 10, 2019Terminated

   The filter capacity is not achieved due to damage of the filter membrane.

   Z-2466-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionMar 7, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE EVENT DESCRIPTION: "CATHETER BROKE DOWN IN PATIENT BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549633 ↗
• MalfunctionJan 16, 2025Break; Break

  ACCORDING EVENT DESCRIPTION: CATHETER SNAPPED DURING INSERTION OF EPIDURAL CATHETER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170736 ↗