OptiMap™ Catheter - 50mm FG0003-50Recalls & reported problems
Cortex, Inc. · The OptiMap™ Catheter is a basket catheter used to detect electrical potentials from the endocardial surfaces of the heart. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850064686067), received between Jun 15, 2026 and Jun 15, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Transmit Record” (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. 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
- Failure to Transmit Record1
Patient problems
- Heart Block1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2026Failure to Transmit Record
DURING A PROCEDURE TO TREAT PERSISTENT ATRIAL FIBRILLATION, A FARAWAVE NAV CATHETER AND AN OPTIMAP CORTEX CATHETER WERE USED. THE LEFT ATRIAL PORTION OF THE PROCEDURE WAS COMPLETED USING THE FARAWAVE CATHETER AFTER PULMONARY VEIN TREATMENT. THE FARAWAVE CATHETER WAS THEN REMOVED, AND THE OPTIMAP CATHETER WAS INSERTED TO VISUALIZE SOURCES ABOVE 25%. THE LEFT ATRIAL PORTION WAS COMPLETED WITHOUT ISSUE. AFTER REPOSITIONING THE FARADRIVE SHEATH INTO THE RIGHT ATRIUM AND REINTRODUCING THE FARAWAVE CATHETER, THE PATIENT EXPERIENCED AN APPROXIMATELY 15-SECOND EPISODE OF HEART BLOCK DURING RIGHT ATRIAL MAPPING. VENTRICULAR RHYTHM RETURNED SPONTANEOUSLY WITHOUT INTERVENTION, AND MAPPING WAS CONTINUED WITH CAUTION. THE FARAWAVE CATHETER WAS EXCHANGED FOR THE OPTIMAP CORTEX CATHETER. THE FIRST OPTIMAP IMAGE SET WAS SUCCESSFULLY OBTAINED, AND THREE SOURCES WERE ABLATED. WHEN OPTIMAPPING WAS ATTEMPTED AGAIN, THE OPTIMAP CATHETER COULD NOT BE VISUALIZED. TROUBLESHOOTING WAS PERFORMED, INCLUDING VERIFICATION OF ALL SYSTEM CONNECTIONS AND RESTARTING THE OPAL SESSION, BUT VISUALIZATION COULD NOT BE RESTORED. THE OPTIMAP CATHETER WAS REMOVED, AND THE FARAWAVE CATHETER WAS REINSERTED TO RECREATE A NE
Patient problems: Heart Block
MAUDE report 25513238 ↗
Other Catheter, Intracardiac Mapping, High-Density Array devices
- PENTARAY NAV D128211Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls6 deaths551 reports
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- 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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