Design Options® 555110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964313653), received between Aug 16, 2022 and Aug 30, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (2 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.

• InjuryAug 30, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: EPIDURAL CATHETER HAD TO BE SURGICALLY REMOVED FROM PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15323662 ↗
• InjuryAug 24, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE THE INTACT EPIDURAL. THE NEUROSURGEON FOUND A DEFECT IN THE CATHETER SHEATH ON REMOVAL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281455 ↗
• InjuryAug 16, 2022Difficult to Remove

  EPIDURAL CATHETER UNABLE TO BE REMOVED, REQUIRED SURGICAL REMOVAL. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15242082 ↗