Home › Device types › OAD
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA product code OAD · Class 3 · Unknown
301
Registered devices
5,946
Adverse events
22
Recalls
0
510(k) clearances
Devices with this code
Maestro 4000™ Controller — BOSTON SCIENTIFIC CORPORATIONCable, Maestro 4000™ — BOSTON SCIENTIFIC CORPORATIONIntellaNav™ Open-Irrigated — BOSTON SCIENTIFIC CORPORATIONThermoCool SF NAV — Biosense Webster IncIntellaTip MiFi™ XP — BOSTON SCIENTIFIC CORPORATIONINTELLAGEN™ Remote Control Connection Cable (10m) — Stockert GmbHQDOT MICRO — Biosense Webster IncMaestro 4000™ Controller — BOSTON SCIENTIFIC CORPORATIONTherapy™ — IRVINE BIOMEDICAL, INC.N/A — Biosense Webster IncnGEN Generator — Biosense Webster IncN/A — Biosense Webster IncFlexAbility™ — ST. JUDE MEDICAL, INC.INTELLAGEN™ Remote Control Connection Cable (30m) — Stockert GmbHEZ Steer NAV DS — Biosense Webster IncQDOT MICRO — Biosense Webster IncBlazer® Open-Irrigated — BOSTON SCIENTIFIC CORPORATIONFlexAbility™ — ST. JUDE MEDICAL, INC.INTELLAGEN™ Remote Control Connection Cable (15m) — Stockert GmbHSafire™ Blu™ SP — IRVINE BIOMEDICAL, INC.Ampere™ — ST. JUDE MEDICAL, INC.EZ Steer NAV DS — Biosense Webster IncEZ Steer NAV DS — Biosense Webster IncNaviStar ThermoCool — Biosense Webster Inc
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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