Perifix® 332079 (UDI 04046955899456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046955899456), received between Mar 13, 2025 and Sep 25, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 18, 2025Open, Classified

   Potential for the lid of the catheter connector to be in the incorrect position.

   Z-0116-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  As reported by the user facility:CRNA did an epidural on a patient and had an issue when he went to attach the connector. The end was frayed so he had to pull out and redo entire epidural.No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896570 ↗
• MalfunctionSep 15, 2026Break

  As reported by the user facility:Event 2:Epidural Catheter separationTwo epidural catheters broke off prior to completion of therapy, springwound coil became exposed. One catheter was missing tip and was not sealed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775188 ↗
• MalfunctionAug 7, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173283 ↗
• MalfunctionAug 7, 2026Difficult to Remove

  As reported by the user facility:Event 1:The epidural catheter ended up in a knot.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173280 ↗
• MalfunctionDec 9, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DESCRIBE EVENT OR PROBLEM: RETAINED EPIDURAL CATHETER FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23763159 ↗
• MalfunctionMar 13, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DESCRIPTION AS REPORTED: IT WAS REPORTED THAT THE TUBING IN 7205040 TRAY EPIDURAL PERIFIX W/CATH HAS SEPARATED DURING SOME PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599320 ↗
• MalfunctionMar 13, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DESCRIPTION AS REPORTED: IT WAS REPORTED THAT THE TUBING IN 7205040 TRAY EPIDURAL PERIFIX W/CATH HAS SEPARATED DURING SOME PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593941 ↗