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Fast-Cath™ 406783Recalls & reported problems

St. Jude Medical, Inc. · Hemostasis Introducer · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734012942), received between Jun 28, 2023 and Jun 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Activation, Positioning or Separation Problem1
  • Difficult to Insert1

Patient problems

  • Cardiac Arrest1
  • Cardiac Perforation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 28, 2023Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem

    FOLLOW UP REPORT NEEDED TO INCLUDE UPDATED MEDICAL DEVICE PROBLEM A CODE.

    Patient problems: Cardiac Arrest; Cardiac Perforation

    MAUDE report 17221381 ↗

Other INTRODUCER, CATHETER devices

All INTRODUCER, CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.