Fast-Cath™ 406773Recalls & 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 05414734011785), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2024Break; Off-Label Use; Break; Off-Label Use
DURING THE BIOPSY PROCEDURE, IT WAS IMPOSSIBLE TO MOUNT THE BIOPSY FORCEPS IN THE INTRODUCER. THE INTRODUCER WAS REMOVED AND DAMAGE WAS NOTED. NO DAMAGE WAS NOTED TO THE NON-ABBOTT BIOPSY FORCEPS. THE DEVICE WAS NOT EXCHANGED, AND THE BIOPSY PROCEDURE WAS NOT PERFORMED. THERE WERE NO ADVERSE PATIENT HEALTH CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19623830 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.