Perifix® 333521Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964179945), received between Sep 24, 2019 and Feb 5, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

• MalfunctionFeb 5, 2026Break

  AS REPORTED BY THE USER FACILITY: CATHETER TIP BROKE OFF AT END OF TUOHY NEEDLE WHEN USED FOR PERIPHERAL BLOCK. FOREIGN MATTER REMAINS IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24267575 ↗
• MalfunctionSep 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE CATHETER CONNECTORS DO NOT STAY CLOSED. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112722 ↗
• MalfunctionSep 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE CATHETER CONNECTORS DO NOT STAY CLOSED. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112717 ↗