Design Options® 552083Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964675669), received between Dec 20, 2017 and Dec 20, 2017 — 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.

• InjuryDec 20, 2017Break; Break

  AS REPORTED BY USER FACILITY: "DURING INSERTION THE EPIDURAL CATHETER WAS PULLED BACK FOR PROPER POSITIONING WHEN ABNORMAL RESISTANCE WAS FELT. BASED ON THIS FINDING DECISION WAS MADE TO REMOVE CATHETER. ONCE REMOVED THE "BLACK" MARKER AT THE TIP OF THE CATHETER WAS NOT PRESENT. THE TIP HAD A SHREDDED APPEARANCE AND SEVERAL CENTIMETERS OF INTERNAL WIRE WAS SEEN. THE PATIENT WAS GIVEN THE OPTION TO ATTEMPT SURGICAL REMOVAL OF FOREIGN BODY BUT DECLINED."

  Patient problems: Foreign Body In Patient

  MAUDE report 7135374 ↗