FlexAbility™ A-FASE-DDRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067020055), received between Jan 10, 2022 and Sep 20, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Pacing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Cardiac Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2024Fracture; Fracture
THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER SHAFT DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20268488 ↗InjuryMar 3, 2023Pacing Problem; Pacing Problem
DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. PACE MAPPING WITH THE ABLATION CATHETER WOULD CAPTURE INTERMITTENTLY IN THE LEFT VENTRICLE AT DIFFERENT LOCATIONS. POST ABLATION, DURING THE WAITING PERIOD, A PERICARDIAL EFFUSION WAS NOTED. NO INTERVENTION WAS REPORTED AND THE PATIENT IS IN STABLE CONDITION. THE PHYSICIAN BELIEVES THE EFFUSION WAS DUE TO PATIENT MOVEMENT.
Patient problems: Cardiac Perforation
MAUDE report 16478189 ↗MalfunctionJan 10, 2022Fracture; Fracture
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURED CATHETER SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13207126 ↗
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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