Design Options® 555422Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964315534), received between Aug 9, 2019 and Aug 15, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• MalfunctionAug 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE CATHETER CONNECTOR BECAME DISLODGED FROM THE TUBING, AND THE EPIDURAL HAD TO BE REPLACED. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8896803 ↗
• MalfunctionAug 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS HAVING ISSUES WITH THE CATHETER CONNECTOR. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8879939 ↗