FlexAbility™ A-FASE-FFRecalls & reported problems
St. Jude Medical, Inc. · Ablation Catheter · Class 3
All models of FlexAbility (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067020079), received between Jul 18, 2018 and Jul 18, 2018 — classified as 1 death.
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
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJul 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2018-00197, 3008452825-2018-00232, 2182269-2018-00086. DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND EXPIRED. AFTER TRANSSEPTAL ACCESS WAS OBTAINED AND MAPPING OF THE LEFT VENTRICLE WAS PERFORMED, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM WAS PERFORMED BUT THERE WAS NO PRESENCE OF A PERICARDIAL EFFUSION OR CARDIAC PERFORATION. THE PATIENT¿S BLOOD PRESSURE CONTINUED TO DROP AND HE SUBSEQUENTLY DIED. THE CAUSE OF THE DEATH IS UNKNOWN BUT THOUGHT TO BE DUE TO RESPIRATORY FAILURE OR PREEXISTING PATIENT CONDITIONS. THERE WERE NO ALLEGED DEFICIENCIES WITH ANY ABBOTT DEVICES.
Patient problems: Death
MAUDE report 7697784 ↗
Other catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices
- QDOT MICRO D139505Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter27 deaths915 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR96200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths269 reports
- QDOT MICRO D139504Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter7 deaths138 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 recall5 deaths77 reports
- QDOT MICRO D139401Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths114 reports
- NaviStar ThermoCool NI75TCDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter111 reports
- NaviStar RMT ThermoCool NR7TCSIYBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter9 deaths103 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR9620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter78 reports
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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