Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA adverse event reports and recall history for catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation (product code OAE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 11,328
- Deaths
- 343
- Injuries
- 5,432
- Malfunctions
- 5,549
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-10-10Open, ClassifiedPackage design/selection
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-10Open, ClassifiedPackage design/selection
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-10Open, ClassifiedPackage design/selection
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-10Open, ClassifiedPackage design/selection
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-10Open, ClassifiedPackage design/selection
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-03-10Open, ClassifiedProcess control
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
- 2024-11-12Open, ClassifiedDevice Design
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-12Open, ClassifiedDevice Design
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-12Open, ClassifiedDevice Design
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-12Open, ClassifiedDevice Design
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Monitor catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation automatically
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