Design Options® 551028Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964306334), received between Jul 9, 2025 and Jul 9, 2025 — 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.

• MalfunctionJul 9, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DESCRIPTION OF EVENT: DURING AN EPIDURAL PLACEMENT FOR A PATIENT IN LABOR, THE EPIDURAL CATHETER WAS FOUND TO HAVE SHEARED. THE CATHETER SEPARATED AT THE 5-CENTIMETER MARK. WE BELIEVE IT IS IMPORTANT TO NOTE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THE PRACTITIONER'S TECHNIQUE DURING THE PLACEMENT AND/OR REMOVAL ATTEMPT MAY NOT HAVE FOLLOWED ALL RECOMMENDED SAFETY PRECAUTIONS, WHICH COULD HAVE BEEN A CAUSATIVE FACTOR IN THE CATHETER SHEARING. PATIENT STATUS AND MANAGEMENT: THE PATIENT IS CURRENTLY STILL IN LABOR. THE DECISION REGARDING THE MANAGEMENT OF THE RETAINED CATHETER FRAGMENT (IN-SITU VS. SURGICAL REMOVAL) IS CURRENTLY UNDER CONSIDERATION BY THE CLINICAL TEAM, PENDING FURTHER EVALUATION. AN ULTRASOUND WAS PERFORMED, BUT THE FRAGMENT WAS NOT VISUALIZED. A CT SCAN HAS NOT YET BEEN PERFORMED BUT WILL OCCUR AS PART OF THE DIAGNOSTIC WORKUP AFTER PATIENT DELIVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22457225 ↗