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FIRMap AR064050Recalls & reported problems

Abbott · FIRMap Catheter 50mm, PACKAGED - Abbott (Global) · 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 00810591020017), received between Jul 10, 2019 and Jul 10, 2019 — 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

  • Cardiac Perforation1

Recent adverse event reports

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

  • InjuryJul 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING AN ATRIAL FIBRILLATION ABLATION, A CARDIAC EFFUSION OCCURRED. THE PATIENT BECAME HYPOTENSIVE AND AN INTRACARDIAC ULTRASOUND WAS USED TO VISUALIZE THE PERICARDIUM. A MINIMAL AMOUNT OF PERICARDIAL EFFUSION WAS NOTED BUT NO INTERVENTION OR FURTHER TREATMENT WAS ADMINISTERED. DESPITE THE BLOOD PRESSURE NORMALIZING, THE PROCEDURE WAS CANCELLED. THE PATIENT WAS STABILIZED.

    Patient problems: Cardiac Perforation

    MAUDE report 8778864 ↗

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Sources and updates

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