Perifix® 332209Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964178160), received between Dec 10, 2018 and Jan 6, 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.

• MalfunctionJan 6, 2023Break; Break

  AS REPORTED PER (B)(4): EPIDURAL CATHETER SHEARED OFF AT APPROXIMATELY 5.5CM, WITH DISTAL PORTION RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16116265 ↗
• MalfunctionDec 28, 2022Break

  EPIDURAL CATHETER SHEARED OFF AT APPROXIMATELY 5.5CM, WITH DISTAL PORTION RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16060478 ↗
• MalfunctionDec 10, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: END USER REPORTS: "WE HAD A PERFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY THAT WAS PLACED IN A PATIENT. WHEN ANESTHESIA REMOVED IT, PART OF THE END BROKE OFF INTO THE PATIENT." THE CATHETER HAD BEEN IN PLACE APX. 6.5 HOURS. 1/4 INCH WAS RETAINED IN THE PATIENT HAD NO SIGNS AND SYMPTOMS FROM CATHETER PIECE. DECISION MADE TO REMAIN IN PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8148463 ↗