Home › Device types › OAE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA product code OAE · Class 3 · Unknown
182
Registered devices
11,392
Adverse events
34
Recalls
0
510(k) clearances
Devices with this code
DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.QDOT MICRO — Biosense Webster IncFreezor® MAX — MEDTRONIC, INC.nGEN Generator — Biosense Webster IncQDOT MICRO — Biosense Webster IncTactiCath™ — ST. JUDE MEDICAL, INC.Freezor® MAX — MEDTRONIC, INC.HeartLight — CARDIOFOCUS, INC.DiamondTemp™ Foot Switch — MEDTRONIC, INC.Arctic Front® — MEDTRONIC, INC.Ampere™ — ST. JUDE MEDICAL, INC.SMARTFREEZE™ — BOSTON SCIENTIFIC CORPORATIONTactiCath™ — ST. JUDE MEDICAL, INC.NA — MEDTRONIC, INC.Ampere™ — ST. JUDE MEDICAL, INC.NA — MEDTRONIC, INC.DiamondTemp™ Unidirectional Ablation Catheter — MEDTRONIC, INC.Arctic Front Advance™ — MEDTRONIC, INC.TactiSys™ — ST. JUDE MEDICAL, INC.HexaGen™ RF Generator — MEDTRONIC, INC.Arctic Front Advance™ — MEDTRONIC, INC.QDOT MICRO — Biosense Webster IncSMARTFREEZE™ — BOSTON SCIENTIFIC CORPORATIONArctic Front Advance™ — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-02-07 | CardioFocus, Inc. | Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. |
| 2024-10-10 | Boston Scientific Corporation | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
| 2024-10-10 | Boston Scientific Corporation | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
| 2024-10-10 | Boston Scientific Corporation | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
| 2024-10-10 | Boston Scientific Corporation | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
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