MTD

Death

22

Injury

376

Malfunction

986

Total

1,384

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50) Cortex, Inc. · 2026-03-13
• K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009) Medtronic · 2024-08-07
• K241372 — Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ ABBOTT MEDICAL · 2024-07-09
• K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID Biosense Webster, Inc. · 2023-07-10
• K223666 — Ablacath™ Mapping Catheter Ablacon, Inc. · 2023-03-17
• K230253 — OPTRELL™ Mapping Catheter with TRUEref™ Technology Biosense Webster, Inc. · 2023-03-02
• K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009 Acutus Medical, Inc. · 2022-06-21
• K211438 — OPTRELL Mapping Catheter with TRUEref Technology Biosense Webster, Inc. · 2022-03-18
• K201806 — Reprocessed PentaRay Nav eco High-Density Mapping Catheter Sterilmed Inc. (Johnson and Johnson) · 2021-06-23
• K201341 — AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc. · 2020-09-15
• K200212 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled Innovative Health, LLC · 2020-09-03
• K201750 — Pentaray Nav eco High-Density Mapping Catheter Biosense Webster, Inc. · 2020-08-06
• K193237 — Carto Octaray Mapping Catheter with Trueref Technology Biosense Webster, Inc. · 2020-07-31
• K172393 — Advisor HD Grid Mapping Catheter, Sensor Enabled St. Jude Medical, Inc. · 2018-04-23
• K170819 — AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc. · 2017-10-16
• K163709 — FIRMap Catheter Abbott Electrophysiology · 2017-02-28
• K153093 — FIRMap Catheter Abbott Electrophysiology · 2016-04-07
• K142182 — FRIMAP ADAPTER CONNECTOR (MAC) Topera, Inc. · 2014-09-09
• K140733 — CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER Boston Scientific Corporation · 2014-04-28
• K130827 — FIRMAP CATHETER Topera, Inc. · 2013-10-31
• K123837 — PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc. · 2013-03-05
• K120425 — PENTARAY NAV HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc. · 2012-05-24
• K121006 — ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER St Jude Medical · 2012-05-03
• K050217 — FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) Biosense Webster, Inc. · 2005-03-30
• K021232 — CONSTELLATION CATHETERS, MODEL 8031M Boston Scientific Corp · 2002-05-16
• K012926 — MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. · 2001-09-28
• K003782 — CONSTELLATION CATHETER, MODEL 8031 Boston Scientific Corp · 2001-02-14
• K000277 — CONSTELLATION CATHETERS Boston Scientific Corp · 2000-09-26
• K992777 — CONSTELLATION CATHETERS, MODEL 8039 Boston Scientific Corp · 1999-11-12
• K990795 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES Cardiac Pathways Corp. · 1999-06-08
• K983456 — ENSITE 3000 SYSTEM Endocardial Solutions, Inc. · 1999-04-21
• K983171 — CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM Boston Scientific Corp · 1999-03-11
• K982540 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, Cardiac Pathways Corp. · 1999-01-27