Design Options® 551951Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964309472), received between Nov 21, 2022 and Nov 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

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.

• MalfunctionNov 21, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: DESCRIPTION OF THE PATIENT EVENT: CATHETER TIP BROKE OFF INSIDE PATIENT. THEY DID DO IMAGING STUDIES AND DID NOT FIND THE BROKEN PIECE. THERE WAS NO INTERVENTION OTHER THAN MONITORING PATIENT, NO NEURO DEFICITS OR MOTOR DEFICITS WERE NOTED. PATIENT WAS EVENTUALLY DISCHARGED HOME WITH NO FURTHER ISSUES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833415 ↗