Catheter,Intracardiac Mapping,High-Density Array

FDA product code MTD · Class 2 · 28 devices · 1,328 reports · 12 deaths reported · 12 devices named in recalls

• PENTARAY NAV D128211

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls6 deaths551 reports
• PENTARAY NAV D128208

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls2 deaths237 reports
• OCTARAY Mapping Catheter D160903

  Biosense Webster Inc · Catheter, intracardiac mapping, high-density array
  146 reports
• PENTARAY NAV D128210

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls31 reports
• PENTARAY NAV D128207

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls15 reports
• OCTARAY Mapping Catheter D160901

  Biosense Webster Inc · Catheter, intracardiac mapping, high-density array
  1 death113 reports
• PENTARAY NAV D128201

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls6 reports
• PENTARAY NAV D128203

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls1 report
• PENTARAY NAV D128205

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls1 death1 report
• PENTARAY NAV D128202

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls0 reports
• PENTARAY NAV D128204

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls0 reports
• PENTARAY NAV D128206

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls0 reports
• PENTARAY NAV D128209

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls0 reports
• OCTARAY Mapping Catheter D160906

  Biosense Webster Inc · Catheter, intracardiac mapping, high-density array
  2 deaths61 reports
• PENTARAY NAV D128212

  Biosense Webster Inc · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  1 recall0 reports
• OCTARAY Mapping Catheter D160904

  Biosense Webster Inc · Catheter, intracardiac mapping, high-density array
  48 reports
• OPTRELL Mapping Catheter with TRUEref Technology D142901

  Biosense Webster Inc · Catheter, intracardiac mapping, high-density array
  41 reports
• OCTARAY Mapping Catheter D160902

  Biosense Webster Inc · Catheter, intracardiac mapping, high-density array
  24 reports
• Advisor™ HD Grid X, Sensor Enabled™ D-AVHDX-DF16

  St. Jude Medical, Inc. · Catheter, intracardiac mapping, high-density array
  20 reports
• OCTARAY Mapping Catheter D160905

  Biosense Webster Inc · Catheter, intracardiac mapping, high-density array
  15 reports
• AcQMap 900003

  Acutus Medical, Inc. · Catheter,Intracardiac Mapping,High-Density Array
  5 reports
• OPTRELL Mapping Catheter with TRUEref Technology D142902

  Biosense Webster Inc · Catheter, intracardiac mapping, high-density array
  5 reports
• EnSite™ EC1000

  St. Jude Medical, Inc. · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 reports
• CARTO 3 System eco Interface Cable D134402

  Biosense Webster Inc · Catheter, intracardiac mapping, high-density array
  2 reports
• FIRMap AR064050

  Abbott · CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  1 report
• OptiMap™ Catheter - 50mm FG0003-50

  Cortex, Inc. · Catheter, Intracardiac Mapping, High-Density Array
  1 report
• Ablacon™ Mapping Catheter AB-0003-50

  Ablacon Inc. · Catheter, Intracardiac Mapping, High-Density Array
  1 report
• NA RD128208

  Sterilmed, Inc. · Catheter, intracardiac mapping, high-density array
  1 report