Design Options® 530048Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964305313), received between Aug 31, 2018 and Aug 31, 2018 — 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-0124-2026 · 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.

• MalfunctionAug 31, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE CLINICIAN WAS INSERTING CATHETER THROUGH TUOHY NEEDLE AND MET RESISTANCE WHEN TRYING TO REMOVE THE NEEDLE. WHEN REMOVING THE CATHETER THROUGH THE NEEDLE, THE CATHETER SHEARED. THE CLINICIAN WAS ABLE TO REMOVE THE WIRE PORTION OF CATHETER AT THAT TIME. ABOUT SIX CM OF CATHETER REMAINED IN PATIENT. A NEW SPINAL ONE LEVEL DOWN WAS DONE AND AFTER SPINAL WAS ABLE TO REMOVE THE REMAINING PORTION OF THE CATHETER FROM PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7837121 ↗