Permanent defibrillator electrodes

FDA product code NVY · Class 3 · 181 devices · 148,636 reports · 2,036 deaths reported · 8 devices named in recalls

• CapSureFix Novus MRI™ SureScan® 5076-52

  Medtronic, Inc. · Permanent defibrillator electrodes
  333 deaths30,581 reports
• Sprint Quattro Secure S MRI™ SureScan™ 6935M62

  Medtronic, Inc. · Permanent defibrillator electrodes
  221 deaths14,405 reports
• Capsurefix® Novus 5076-52

  Medtronic, Inc. · Permanent defibrillator electrodes
  111 deaths9,860 reports
• CapSureFix Novus MRI™ SureScan® 5076-52

  Medtronic, Inc. · Permanent defibrillator electrodes
  80 deaths8,280 reports
• Sprint Quattro Secure S MRI™ SureScan™ 6935M55

  Medtronic, Inc. · Permanent defibrillator electrodes
  116 deaths7,750 reports
• Durata™ 7122Q-58

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  151 deaths6,202 reports
• Durata™ 7122Q-65

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  86 deaths4,773 reports
• Capsurefix® Novus 5076-58

  Medtronic, Inc. · Permanent defibrillator electrodes
  47 deaths4,587 reports
• ENDOTAK RELIANCE® SG 0292

  Boston Scientific Corporation · Permanent defibrillator electrodes
  16 deaths3,197 reports
• Tendril™ ST

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  74 deaths3,093 reports
• RELIANCE 4-FRONT™ 0672

  Boston Scientific Corporation · Permanent defibrillator electrodes
  13 deaths2,895 reports
• OPTISURE™ LDA210Q-58

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  69 deaths2,441 reports
• RELIANCE 4-FRONT™ 0673

  Boston Scientific Corporation · Permanent defibrillator electrodes
  10 deaths2,173 reports
• Durata™ 7120Q-58

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  59 deaths2,092 reports
• ENDOTAK RELIANCE® SG 0293

  Boston Scientific Corporation · Permanent defibrillator electrodes
  8 deaths2,039 reports
• Isoflex™ 1948-58

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  26 deaths2,015 reports
• Sprint Quattro Secure S® 6935M62

  Medtronic, Inc. · Permanent defibrillator electrodes
  33 deaths1,731 reports
• OPTISURE™ LDA210Q-65

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  43 deaths1,706 reports
• Tendril™ ST

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  21 deaths1,673 reports
• Isoflex™ 1944-52

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  12 deaths1,647 reports
• Plexa ProMRI S 65

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  9 deaths1,592 reports
• CapSureFix Novus MRI™ SureScan® 5076-45

  Medtronic, Inc. · Permanent defibrillator electrodes
  9 deaths1,251 reports
• CapSureFix MRI™ SureScan™ 5086MRI58

  Medtronic, Inc. · Permanent defibrillator electrodes
  9 deaths1,196 reports
• Tendril™ ST

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  46 deaths1,164 reports
• Sprint Quattro Secure® 6947M62

  Medtronic, Inc. · Permanent defibrillator electrodes
  18 deaths1,158 reports
• Durata™ 7120Q-65

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  32 deaths1,140 reports
• ENDOTAK RELIANCE® G 0295

  Boston Scientific Corporation · Permanent defibrillator electrodes
  1 recall9 deaths1,070 reports
• Sprint Quattro Secure S™ DXAC/DSP 693565

  Medtronic, Inc. · Permanent defibrillator electrodes
  11 deaths1,012 reports
• Sprint Quattro Secure S® 6935M55

  Medtronic, Inc. · Permanent defibrillator electrodes
  13 deaths998 reports
• CapSure Sense MRI™ SureScan™ 457453

  Medtronic, Inc. · Permanent defibrillator electrodes
  7 deaths961 reports
• ENDOTAK RELIANCE® G 0296

  Boston Scientific Corporation · Permanent defibrillator electrodes
  1 recall4 deaths862 reports
• Sprint Quattro Secure® DXAC/DSP 694765

  Medtronic, Inc. · Permanent defibrillator electrodes
  10 deaths852 reports
• Sprint Quattro Secure® 6947M62

  Medtronic, Inc. · Permanent defibrillator electrodes
  10 deaths796 reports
• Plexa ProMRI S DX 65/15

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  1 death762 reports
• Sprint Quattro Secure S® 6935M62

  Medtronic, Inc. · Permanent defibrillator electrodes
  11 deaths735 reports
• Sprint Quattro Secure S™ 693565

  Medtronic, Inc. · Permanent defibrillator electrodes
  10 deaths657 reports
• Isoflex™ 1948-52

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  20 deaths653 reports
• Plexa ProMRI DF-1 S DX 65/15

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  652 reports
• Epsila EV™ MRI SureScan™ EV240163

  Medtronic, Inc. · Permanent defibrillator electrodes
  13 deaths634 reports
• Linox Smart S DX 65/15 365500

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  1 death632 reports
• Sprint Quattro Secure S™ DXAC/DSP 693558

  Medtronic, Inc. · Permanent defibrillator electrodes
  3 deaths607 reports
• SelectSecure™ MRI SureScan™ 383059

  Medtronic, Inc. · Permanent defibrillator electrodes
  18 deaths574 reports
• Tendril™ ST

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  15 deaths547 reports
• Durata™ 7121Q-58

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  27 deaths529 reports
• ENDOTAK RELIANCE® S 640272-103

  Boston Scientific Corporation · Permanent defibrillator electrodes
  3 deaths516 reports
• Durata™ 7122Q-52

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  13 deaths510 reports
• Durata™ 7121Q-65

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  21 deaths478 reports
• SelectSecure™ MRI SureScan™ 383059

  Medtronic, Inc. · Permanent defibrillator electrodes
  3 deaths450 reports
• Sprint Quattro Secure S® 6935M55

  Medtronic, Inc. · Permanent defibrillator electrodes
  2 deaths449 reports
• Capsure® EPI 4968-35

  Medtronic, Inc. · Permanent defibrillator electrodes
  6 deaths438 reports
• Tendril™ ST

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  16 deaths398 reports
• Protego S 65 379969

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  393 reports
• ENDOTAK RELIANCE® S 640273-103

  Boston Scientific Corporation · Permanent defibrillator electrodes
  2 deaths391 reports
• Capsure®SP Novus 5092-58

  Medtronic, Inc. · Permanent defibrillator electrodes
  3 deaths350 reports
• OPTISURE™ LDA220Q-58

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  19 deaths334 reports
• CapSureFix Novus MRI™ SureScan™ 5076-52

  Medtronic, Inc. · Permanent defibrillator electrodes
  5 deaths329 reports
• Isoflex™ 1944-46

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  7 deaths329 reports
• Sprint Quattro Secure S MRI™ SureScan™ 6935M62

  Medtronic, Inc. · Permanent defibrillator electrodes
  3 deaths309 reports
• RELIANCE 4-FRONT™ 0675

  Boston Scientific Corporation · Permanent defibrillator electrodes
  3 deaths301 reports
• Plexa ProMRI SD 65/18

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  294 reports
• Linox Smart S DX 65/17 365501

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  290 reports
• Durata™ 7120Q-52

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  11 deaths289 reports
• OPTISURE™ LDA220Q-65

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  9 deaths266 reports
• RELIANCE 4-FRONT™ 0676

  Boston Scientific Corporation · Permanent defibrillator electrodes
  261 reports
• ACUITY™ Steerable 4555

  Boston Scientific Corporation · Permanent defibrillator electrodes
  2 deaths247 reports
• Linox Smart S 65 369818

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  237 reports
• CAPSUREFIX® 5568-45

  Medtronic, Inc. · Permanent defibrillator electrodes
  2 deaths235 reports
• Sprint Quattro® 6944-58

  Medtronic, Inc. · Permanent defibrillator electrodes
  6 deaths233 reports
• CapSureFix Novus MRI™ SureScan™ 5076-45

  Medtronic, Inc. · Permanent defibrillator electrodes
  2 deaths232 reports
• OmniaSecure™ MRI SureScan™ 3930M74

  Medtronic, Inc. · Permanent defibrillator electrodes
  3 deaths228 reports
• Pamira S DX 65/15 428775

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  212 reports
• CAPSUREFIX® 5568-53

  Medtronic, Inc. · Permanent defibrillator electrodes
  1 death209 reports
• CAPSURE® SENSE 457453

  Medtronic, Inc. · Permanent defibrillator electrodes
  2 deaths198 reports
• Plexa ProMRI S 60 402265

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  1 death198 reports
• Plexa ProMRI S DX 65/17

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  197 reports
• Linox Smart SD 65/18 359067

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  1 death193 reports
• CapSure®SP Novus 4092-58

  Medtronic, Inc. · Permanent defibrillator electrodes
  3 deaths185 reports
• Capsurefix® DXAC/DSP 5568-53

  Medtronic, Inc. · Permanent defibrillator electrodes
  1 death180 reports
• Plexa ProMRI DF-1 S DX 65/17

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  175 reports
• Sprint Quattro Secure S® 6935M72

  Medtronic, Inc. · Permanent defibrillator electrodes
  1 recall1 death120 reports
• Durata™ 7170Q-58

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  3 deaths166 reports
• ACUITY™ Steerable 4554

  Boston Scientific Corporation · Permanent defibrillator electrodes
  149 reports
• Optisure™ LDA210

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  6 deaths147 reports
• ENDOTAK RELIANCE® SG 0282

  Boston Scientific Corporation · Permanent defibrillator electrodes
  1 recall95 reports
• ENDOTAK RELIANCE® G 0285

  Boston Scientific Corporation · Permanent defibrillator electrodes
  1 recall1 death92 reports
• OPTISURE™ LDA210Q-52

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  4 deaths141 reports
• CapSure®SP Novus 5592-53

  Medtronic, Inc. · Permanent defibrillator electrodes
  3 deaths140 reports
• ENDOTAK RELIANCE® G 0286

  Boston Scientific Corporation · Permanent defibrillator electrodes
  1 recall83 reports
• Protego SD 65/18 399410

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  122 reports
• Sprint Quattro Secure MRI™ SureScan™ 694765

  Medtronic, Inc. · Permanent defibrillator electrodes
  1 death114 reports
• Protego S 60 379970

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  113 reports
• Linox Smart SD 60/16 359065

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  107 reports
• ENDOTAK RELIANCE® SG 0283

  Boston Scientific Corporation · Permanent defibrillator electrodes
  1 recall1 death49 reports
• Durata™ 7170Q-65

  St. Jude Medical, Inc. · Permanent defibrillator electrodes
  1 death97 reports
• ENDOTAK RELIANCE® 0275

  Boston Scientific Corporation · Permanent defibrillator electrodes
  90 reports
• Selectsecure™ 383059

  Medtronic, Inc. · Permanent defibrillator electrodes
  86 reports
• CAPSUREFIX® NOVUS 407658

  Medtronic, Inc. · Permanent defibrillator electrodes
  86 reports
• Linox Smart SD 65/16 359066

  BIOTRONIK SE & Co. KG · Permanent defibrillator electrodes
  1 death82 reports
• OmniaSecure™ MRI SureScan™ 3930M79

  Medtronic, Inc. · Permanent defibrillator electrodes
  1 death74 reports
• ENDOTAK RELIANCE® 0276

  Boston Scientific Corporation · Permanent defibrillator electrodes
  2 deaths74 reports