Design Options® 530193Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046955589364), received between Oct 24, 2023 and Oct 24, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: BREAKING FX CATHETERS IN PATIENTS. DETAILED INQUIRY DESCRIPTION: HOSPITAL REPORTS 3 SEPARATE INCIDENTS OF FX CATHETERS BREAKING IN PATIENTS BACKS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17999614 ↗
• MalfunctionOct 24, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION: BREAKING FX CATHETERS IN PATIENTS. DETAILED INQUIRY DESCRIPTION: HOSPITAL REPORTS 3 SEPARATE INCIDENTS OF FX CATHETERS BREAKING IN PATIENTS BACKS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17999601 ↗
• MalfunctionOct 24, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION: BREAKING FX CATHETERS IN PATIENTS. DETAILED INQUIRY DESCRIPTION: HOSPITAL REPORTS 3 SEPARATE INCIDENTS OF FX CATHETERS BREAKING IN PATIENTS BACKS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17999600 ↗