Design Options® 530155Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964306211), received between May 13, 2019 and May 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Recalls naming this device

1. Sep 18, 2025Open, Classified

   Potential for the lid of the catheter connector to be in the incorrect position.

   Z-0124-2026 · Root cause: Process control · 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.

• MalfunctionMay 13, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: THE BLUE TIP OF THE EPIDURAL CATHETER BROKE OFF WITHIN A PATIENT DURING USE. THE CLINICIAN WAS REMOVING THE CATHETER WHEN RESISTANCE WAS MET. WHEN THE CATHETER WAS PULLED AND REMOVED, THE TIP WAS NOT INTACT. A CT WAS PERFORMED, BUT THE TIP WAS NOT SEEN ON IMAGING. THE PATIENT HAS NORMAL VITALS AND A NORMAL NEUROLOGICAL ASSESMENT AT THE TIME OF THE INCIDENT. THE FACILITY WILL CONTINUE TO MONITOR THE STATUS OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8603384 ↗