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ENGAGE™ C408504Recalls & reported problems

St. Jude Medical, Inc. · Introducer; 8F-ACT · 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 05414734052856), received between Aug 21, 2018 and Aug 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (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

  • Difficult to Insert1

Patient problems

  • Vascular Dissection1

Recent adverse event reports

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

  • InjuryAug 21, 2018Difficult to Insert; Difficult to Insert

    THE ENGAGE INTRODUCER AND THE DILATOR WERE UNABLE TO BE ADVANCED ON THE GUIDEWIRE DESPITE THE GUIDEWIRE INSERTING WITHOUT PROBLEM. WHEN THE GUIDEWIRE WAS REMOVED, IT WAS KINKED AND THE DILATOR WAS BENT. A HEMATOMA APPEARED IN THE VENOUS LUMEN. ALLEGEDLY A VENOUS DISSECTION OCCURRED.

    Patient problems: Vascular Dissection

    MAUDE report 7801870 ↗

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.