Design Options® 551769Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964308024), received between Mar 9, 2022 and Mar 9, 2022 — 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. How this data works · Data updated Oct 13, 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-0126-2026 · Root cause: Process control · 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.

• MalfunctionMar 9, 2022Break; Difficult to Remove; Break; Difficult to Remove

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CATHETER COULD NOT THREAD OR REMOVE. DETAILED INQUIRY DESCRIPTION: EPIDURAL PLACEMENT WAS ATTEMPTED AND CATHETER WAS THREADED. ANESTHESIA HAD DIFFICULTY THREADING THE CATHETER AND ATTEMPTED TO PULL IT OUT AND THE CATHETER TIP WAS UNABLE TO BE REMOVED. THE CATHETER WAS CUT AND CATHETER TIP SENT TO LAB. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13701357 ↗