Design Options® 555170Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964314001), received between Jul 1, 2022 and Jul 1, 2022 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJul 1, 2022Break; Break

  AS PER MEDWATCH NUMBER: (B)(4). DESCRIPTION: WHILE REMOVING AN EPIDURAL CATHETER THAT HAD BEEN IN PLACE DURING LABOR, THE CATHETER SEPARATED INTO TWO SEGMENTS, THE PLASTIC TUBING SEGMENT AND THE METAL GUIDE WIRE SEGMENT. THE STAFF MEMBER STOPPED CATHETER REMOVAL AND NOTIFIED ANESTHESIA. ANESTHESIA EVALUATED PATIENT, NOTING APPROXIMATELY 12CM RETAINED IN BACK. CT IMAGING COMPLETED AND CATHETER VISIBLE. PATIENT REQUIRED REMOVAL OF CATHETER IN OR (OPERATING ROOM) UNDER GENERAL ANESTHESIA. SURGEON NOTED THE CATHETER DID APPEAR TO BE ADHERED AT THE INTERSPINOUS SPACE AT L1-2 AND POSSIBLY PATIENT'S ANATOMY CONTRIBUTED TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14888435 ↗