Design Options® 552153Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046955214426), received between Nov 9, 2020 and May 9, 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, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BROKEN/SNAPPED FX CATHETER. DETAILED INQUIRY DESCRIPTION: END USER REPORTING A BROKEN FX CATHETER USED ON ONE OF THEIR OR PATIENTS PLACED FOR POST-OP PAIN MANAGEMENT. PATIENT WAS MOVED TO A LATERAL POSITION AND THAT IS WHEN THE CATHETER SNAPPED WITH THE SPRINGWOUND COIL EXPOSED. PER THE DOCTOR, NOTHING UNUSUAL NOTED ABOUT THE CATHETER AND THERE WAS NO EXCESSIVE FORCE OR PULLING OF CATHETER TO HAVE CAUSED THIS. THEY SUSPECT THERE WAS A MATERIAL DEFECT IN THE CATHETER MATERIAL. THEY WERE ONLY VISUALLY ALERTED BY IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997909 ↗
• MalfunctionNov 9, 2020Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE USER FACILITY: "THE CATHETER KNOTTED WHILE PLACING CSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10810486 ↗