Perifix® 332215Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964178245), received between Jan 29, 2020 and May 22, 2023 — classified as 1 injury, 2 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.

• InjuryMay 22, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE CATHETER WAS PLACED IN LABOR & DELIVERY AND BROKE IN THE PATIENTS ACK. PATIENT HAD TO BE TRANSFERRED TO TACOMA GENERAL FOR REMOVAL. UNFORTUNATELY THEY DID NOT KEEP THE PIECE OF CATHETER THAT WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16976415 ↗
• MalfunctionOct 6, 2022Break; Break

  PER MEDWATCH NUMBER MW5111787: DESCRIPTION: EPIDURAL CATHETER PLACED IN LABORING MOM. PATIENT HAD INADEQUATE PAIN RELIEF. WHEN REMOVED FROM PATIENT TO ATTEMPT ANOTHER CATHETER, IT WAS IDENTIFIED THE TIP OF THE CATHETER WAS MISSING.

  Patient problems: Foreign Body In Patient; Inadequate Pain Relief

  MAUDE report 15549637 ↗
• MalfunctionJan 29, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CATHETER BROKE OFF IN A PATIENT AND HAD TO BE SURGICALLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9645290 ↗