Ablacon™ Mapping Catheter AB-0003-50Recalls & reported problems
Ablacon Inc. · The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardial surfaces of the heart. These signals may be used for analysis with mapping systems. The Ablacath™ Mapping Catheter may also be used to deliver externally generated pacing stimuli. · Class 2
Data updated Oct 18, 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 00860457001544), received between Oct 23, 2024 and Oct 23, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Tamponade1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD ATRIAL FIBRILLATION ABLATION PERFORMED ON (B)(6) 2023. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2023 DUE TO MILD CHEST PAIN AND DIFFICULTY BREATHING FOR 2 DAYS. AN ECHOCARDIOGRAM SHOWED A LARGE PERICARDIAL EFFUSION W/TAMPONADE AND PATIENT WAS ADMITTED SAME DAY. PERICARDIOCENTESIS WAS PERFORMED THE NEXT DAY. 610ML FLUID WAS DRAINED. A REPEAT ECHOCARDIOGRAM ON (B)(6) 2023 SHOWED MINIMAL PERICARDIAL EFFUSION. THE PATIENT DECREASED COLCHICINE, ADDED PREDNISONE, CONTINUED ELIQUIS AND PROPAFENONE. INCREASE METOPROLOL TO BID FOR RATE CONTROL. PATIENT WAS DISCHARGED ON (B)(6) 2023.
Patient problems: Cardiac Tamponade; Pericardial Effusion
MAUDE report 20516255 ↗
Other Catheter, Intracardiac Mapping, High-Density Array devices
- PENTARAY NAV D128211Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls6 deaths551 reports
- PENTARAY NAV D128208Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls2 deaths237 reports
- OCTARAY Mapping Catheter D160903Biosense Webster Inc · Catheter, intracardiac mapping, high-density array146 reports
- PENTARAY NAV D128210Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls31 reports
- PENTARAY NAV D128207Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls15 reports
- OCTARAY Mapping Catheter D160901Biosense Webster Inc · Catheter, intracardiac mapping, high-density array1 death113 reports
- PENTARAY NAV D128201Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls6 reports
- PENTARAY NAV D128205Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls1 death1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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