Design Options® 530142Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964305986), received between Jun 1, 2020 and Jun 1, 2020 — 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. 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.

• MalfunctionJun 1, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PERIFIX FX EPIDURAL CATHETER SHEARED DURING REMOVAL PROCEDURE. DETAILS OF EVENT: ANESTHESIOLOGIST REPORTS THAT UPON ATTEMPT TO REMOVE CATHETER FROM PATIENT, RESISTANCE WAS ENCOUNTERED. FURTHER ATTEMPTS TO WITHDRAW CATHETER FROM PATIENT RESULTED IN CATHETER BODY FRACTURE, ELONGATED WITHDRAWAL OF STEEL COIL FROM PATIENT'S BACK, AND APPROXIMATELY 3 CM OF CATHETER BODY FRAGMENT REMAINING SUB-Q IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10104919 ↗