Home › Device types › OAD
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA product code OAD · Class 3 · Unknown
310
Registered devices
5,984
Adverse events
22
Recalls
0
510(k) clearances
Devices with this code
QDOT MICRO — Biosense Webster IncTherapy™ — IRVINE BIOMEDICAL, INC.QDOT MICRO — Biosense Webster IncFlexAbility™ — ST. JUDE MEDICAL, INC.EZ Steer ThermoCool NAV — Biosense Webster IncSafire™ TX — IRVINE BIOMEDICAL, INC.Safire™ Blu™ Duo SP — IRVINE BIOMEDICAL, INC.ThermoCool SF — Biosense Webster IncINTELLAGEN™ Remote Control Connection Cable (30m) — Stockert GmbHBlazer Prime® XP — BOSTON SCIENTIFIC CORPORATIONIntellaTip MiFi™ XP — BOSTON SCIENTIFIC CORPORATIONSafire™ Blu™ Duo SP — IRVINE BIOMEDICAL, INC.Celsius ThermoCool — Biosense Webster IncBlazer® Open-Irrigated — BOSTON SCIENTIFIC CORPORATIONThermoCool SF NAV — Biosense Webster IncINTELLAGEN™ Irrigation Pump Connection Cable (5m) — Stockert GmbHNA — MEDTRONIC, INC.EZ Steer NAV DS — Biosense Webster IncIntellaTip MiFi™ Reference Cable — BOSTON SCIENTIFIC CORPORATIONHexaFlow™ Irrigation Pump — MEDTRONIC, INC.Ampere™ — ST. JUDE MEDICAL, INC.VISITAG EXT PROCESSING UNIT ACCESS — Biosense Webster IncEZ Steer ThermoCool NAV — Biosense Webster IncINTELLAGEN™ Foot Pedal — Stockert GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-11 | Medtronic, Inc. | Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Card |
| 2022-09-07 | Johnson & Johnson Surgical Vision, Inc. | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of |
| 2018-11-28 | Boston Scientific Corporation | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions |
| 2018-11-28 | Boston Scientific Corporation | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions |
| 2018-11-28 | Boston Scientific Corporation | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions |
| 2018-06-20 | Boston Scientific Corporation | Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released. |
| 2015-11-20 | Boston Scientific Corp | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BS |
| 2015-11-20 | Boston Scientific Corp | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BS |
| 2015-11-20 | Boston Scientific Corp | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BS |
| 2015-11-20 | Boston Scientific Corp | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BS |
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