CardiaGuide™ 00884450407448Recalls & reported problems
Merit Medical · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00884450407448), received between Sep 8, 2022 and Sep 8, 2022 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT DURING AN ABLATION PROCEDURE, THE PATIENT DEVELOPED CARDIAC TAMPONADE AFTER THE TRANSSEPTAL PUNCTURE PERFORATED AND THE PATIENT'S PERICARDIUM. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND NEEDED AN EMERGENT PERICARDIOCENTESIS. DURING THE ACUTE PERICARDIOCENTESIS ACCESS ATTEMPT, THE PATIENT'S LIVER WAS HIT, AND THE PATIENT STARTED BLEEDING INTERNALLY. THE PATIENT WAS THEN STABILIZED AND TRANSFERRED TO ANOTHER HOSPITAL FOR SURGICAL INTERVENTION WHERE THE PATIENT EXPIRED. THE DEVICE IS NOT RETURNING FOR INVESTIGATION. ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN COMPLETED IN A TIMELY MANNER. NO ADDITIONAL INFORMATION ABOUT THIS EVENT OR MEDICAL DEVICE USE HAS BEEN PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation
MAUDE report 15380206 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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