heart-valve, non-allograft tissue

FDA product code LWR · Class 3 · 290 devices · 11,897 reports · 403 deaths reported · 2 devices named in recalls

• INSPIRIS RESILIA AORTIC VALVE 11500A

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  2 deaths404 reports
• INSPIRIS RESILIA AORTIC VALVE 11500A

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  385 reports
• PERCEVAL PVS23

  Corcym Canada Corp · heart-valve, non-allograft tissue
  26 deaths337 reports
• MOSAIC® 305C23

  Medtronic, Inc. · heart-valve, non-allograft tissue
  327 reports
• MOSAIC® 305C25

  Medtronic, Inc. · heart-valve, non-allograft tissue
  2 deaths324 reports
• FREESTYLE® FR995-27

  Medtronic, Inc. · heart-valve, non-allograft tissue
  2 deaths318 reports
• FREESTYLE® FR995-29

  Medtronic, Inc. · heart-valve, non-allograft tissue
  288 reports
• FREESTYLE® FR99525

  Medtronic, Inc. · heart-valve, non-allograft tissue
  2 deaths280 reports
• MOSAIC ULTRA® 305U23

  Medtronic, Inc. · heart-valve, non-allograft tissue
  239 reports
• MOSAIC ULTRA® 305U25

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 death234 reports
• INSPIRIS RESILIA AORTIC VALVE 11500A

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  1 death223 reports
• Trifecta™ TF-23A

  St. Jude Medical, Inc. · heart-valve, non-allograft tissue
  22 deaths218 reports
• PERCEVAL PVS21

  Corcym Canada Corp · heart-valve, non-allograft tissue
  15 deaths195 reports
• FREESTYLE® FR995-23

  Medtronic, Inc. · heart-valve, non-allograft tissue
  192 reports
• PERCEVAL PVS25

  Corcym Canada Corp · heart-valve, non-allograft tissue
  13 deaths192 reports
• Trifecta™ TF-21A

  St. Jude Medical, Inc. · heart-valve, non-allograft tissue
  12 deaths191 reports
• MOSAIC® 310C29

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 recall13 deaths133 reports
• MOSAIC® 310C31

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 recall11 deaths126 reports
• MOSAIC® 305C27

  Medtronic, Inc. · heart-valve, non-allograft tissue
  170 reports
• MOSAIC ULTRA® 305U223

  Medtronic, Inc. · heart-valve, non-allograft tissue
  3 deaths163 reports
• MOSAIC® 305C21

  Medtronic, Inc. · heart-valve, non-allograft tissue
  161 reports
• Trifecta™ TFGT-23A

  St. Jude Medical, Inc. · heart-valve, non-allograft tissue
  7 deaths159 reports
• INSPIRIS RESILIA AORTIC VALVE 11500A

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  2 deaths158 reports
• MOSAIC ULTRA® 305U225

  Medtronic, Inc. · heart-valve, non-allograft tissue
  3 deaths151 reports
• MOSAIC ULTRA® 305U221

  Medtronic, Inc. · heart-valve, non-allograft tissue
  135 reports
• FREESTYLE® FR995-27

  Medtronic, Inc. · heart-valve, non-allograft tissue
  10 deaths129 reports
• PERCEVAL PVS27

  Corcym Canada Corp · heart-valve, non-allograft tissue
  11 deaths126 reports
• MOSAIC ULTRA® 305U27

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 death124 reports
• Trifecta™ TFGT-21A

  St. Jude Medical, Inc. · heart-valve, non-allograft tissue
  12 deaths124 reports
• MOSAIC ULTRA® 305U21

  Medtronic, Inc. · heart-valve, non-allograft tissue
  121 reports
• FREESTYLE® FR995-29

  Medtronic, Inc. · heart-valve, non-allograft tissue
  6 deaths118 reports
• Trifecta™ TF-19A

  St. Jude Medical, Inc. · heart-valve, non-allograft tissue
  5 deaths110 reports
• FREESTYLE® FR995-25

  Medtronic, Inc. · heart-valve, non-allograft tissue
  9 deaths100 reports
• Trifecta™ TF-25A

  St. Jude Medical, Inc. · heart-valve, non-allograft tissue
  9 deaths96 reports
• Avalus™ 40025

  Medtronic, Inc. · heart-valve, non-allograft tissue
  4 deaths89 reports
• MOSAIC ULTRA® 305U227

  Medtronic, Inc. · heart-valve, non-allograft tissue
  84 reports
• Avalus™ 40023

  Medtronic, Inc. · heart-valve, non-allograft tissue
  7 deaths83 reports
• MOSAIC® 305C223

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 death80 reports
• Trifecta™ TFGT-25A

  St. Jude Medical, Inc. · heart-valve, non-allograft tissue
  5 deaths80 reports
• MOSAIC ULTRA® 305U223

  Medtronic, Inc. · heart-valve, non-allograft tissue
  2 deaths76 reports
• FREESTYLE® FR995-21

  Medtronic, Inc. · heart-valve, non-allograft tissue
  76 reports
• MOSAIC® 310C29

  Medtronic, Inc. · heart-valve, non-allograft tissue
  2 deaths75 reports
• MOSAIC ULTRA® 305U225

  Medtronic, Inc. · heart-valve, non-allograft tissue
  3 deaths73 reports
• INSPIRIS RESILIA AORTIC VALVE 11500A

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  73 reports
• FREESTYLE® FR995-23

  Medtronic, Inc. · heart-valve, non-allograft tissue
  8 deaths72 reports
• MOSAIC® 310C27

  Medtronic, Inc. · heart-valve, non-allograft tissue
  9 deaths71 reports
• MOSAIC® 305C225

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 death67 reports
• MOSAIC® 310C31

  Medtronic, Inc. · heart-valve, non-allograft tissue
  3 deaths63 reports
• MOSAIC ULTRA® 305U223

  Medtronic, Inc. · heart-valve, non-allograft tissue
  62 reports
• INSPIRIS RESILIA AORTIC VALVE 11500A

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  62 reports
• MOSAIC® 310C33

  Medtronic, Inc. · heart-valve, non-allograft tissue
  4 deaths60 reports
• EDWARDS INTUITY ELITE AORTIC VALVE 8300AB

  Edwards Lifesciences LLC · heart-valve, non-allograft tissue
  60 reports
• Avalus™ 40021

  Medtronic, Inc. · heart-valve, non-allograft tissue
  4 deaths59 reports
• MITRIS RESILIA Mitral Valve 11400M

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  58 reports
• MOSAIC® 310C27

  Medtronic, Inc. · heart-valve, non-allograft tissue
  7 deaths57 reports
• MOSAIC® 305C227

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 death57 reports
• MOSAIC® 305C29

  Medtronic, Inc. · heart-valve, non-allograft tissue
  57 reports
• MOSAIC® 310C25

  Medtronic, Inc. · heart-valve, non-allograft tissue
  14 deaths56 reports
• MOSAIC ULTRA® 305U223

  Medtronic, Inc. · heart-valve, non-allograft tissue
  6 deaths56 reports
• MOSAIC ULTRA® 305U29

  Medtronic, Inc. · heart-valve, non-allograft tissue
  55 reports
• Trifecta™ TFGT-19A

  St. Jude Medical, Inc. · heart-valve, non-allograft tissue
  3 deaths55 reports
• EDWARDS INTUITY ELITE AORTIC VALVE 8300AB

  Edwards Lifesciences LLC · heart-valve, non-allograft tissue
  1 death53 reports
• EDWARDS INTUITY ELITE AORTIC VALVE 8300AB

  Edwards Lifesciences LLC · heart-valve, non-allograft tissue
  1 death52 reports
• MOSAIC® 310C27

  Medtronic, Inc. · heart-valve, non-allograft tissue
  52 reports
• MOSAIC ULTRA® 305U225

  Medtronic, Inc. · heart-valve, non-allograft tissue
  50 reports
• MOSAIC® 305C221

  Medtronic, Inc. · heart-valve, non-allograft tissue
  49 reports
• MITRIS RESILIA Mitral Valve 11400M

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  2 deaths49 reports
• MOSAIC® 310C31

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 death49 reports
• MOSAIC ULTRA® 305U223

  Medtronic, Inc. · heart-valve, non-allograft tissue
  3 deaths48 reports
• Avalus™ 40027

  Medtronic, Inc. · heart-valve, non-allograft tissue
  3 deaths48 reports
• PERCEVAL PLUS PVF-M

  Corcym Canada Corp · heart-valve, non-allograft tissue
  1 death47 reports
• MOSAIC® 310C29

  Medtronic, Inc. · heart-valve, non-allograft tissue
  46 reports
• MOSAIC ULTRA® 305U225

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 death45 reports
• MOSAIC ULTRA® 305U221

  Medtronic, Inc. · heart-valve, non-allograft tissue
  44 reports
• MITROFLOW DLA23

  Corcym Canada Corp · heart-valve, non-allograft tissue
  7 deaths44 reports
• MITROFLOW DLA21

  Corcym Canada Corp · heart-valve, non-allograft tissue
  5 deaths42 reports
• MOSAIC® 305C223

  Medtronic, Inc. · heart-valve, non-allograft tissue
  39 reports
• MOSAIC® 310C33

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 death38 reports
• MOSAIC ULTRA® 305U225

  Medtronic, Inc. · heart-valve, non-allograft tissue
  37 reports
• MOSAIC ULTRA® 305U219

  Medtronic, Inc. · heart-valve, non-allograft tissue
  37 reports
• MITRIS RESILIA Mitral Valve 11400M

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  1 death37 reports
• PERCEVAL PLUS PVF-S

  Corcym Canada Corp · heart-valve, non-allograft tissue
  36 reports
• MOSAIC® 310C25

  Medtronic, Inc. · heart-valve, non-allograft tissue
  2 deaths35 reports
• MOSAIC ULTRA® 305U227

  Medtronic, Inc. · heart-valve, non-allograft tissue
  1 death35 reports
• PERCEVAL PLUS PVF-L

  Corcym Canada Corp · heart-valve, non-allograft tissue
  2 deaths35 reports
• MITROFLOW LXA23

  Corcym Canada Corp · heart-valve, non-allograft tissue
  1 death34 reports
• MOSAIC® 310C25

  Medtronic, Inc. · heart-valve, non-allograft tissue
  32 reports
• CROWN PRT CNA21

  Corcym Canada Corp · heart-valve, non-allograft tissue
  3 deaths31 reports
• PERCEVAL PLUS PVF-XL

  Corcym Canada Corp · heart-valve, non-allograft tissue
  31 reports
• PERCEVAL PLUS PVF-M

  Corcym Srl · Heart-Valve, Non-Allograft Tissue
  31 reports
• MOSAIC ULTRA® 305U227

  Medtronic, Inc. · heart-valve, non-allograft tissue
  30 reports
• Epic™ E200-31M

  St. Jude Medical, Inc. · heart-valve, non-allograft tissue
  2 deaths30 reports
• FREESTYLE® FR995-21

  Medtronic, Inc. · heart-valve, non-allograft tissue
  2 deaths29 reports
• KONECT RESILIA 11060A

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  29 reports
• MITRIS RESILIA Mitral Valve 11400M

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  29 reports
• HANCOCK® II T505C221

  Medtronic, Inc. · heart-valve, non-allograft tissue
  27 reports
• HANCOCK® II T505C223

  Medtronic, Inc. · heart-valve, non-allograft tissue
  27 reports
• MITROFLOW LXA21

  Corcym Canada Corp · heart-valve, non-allograft tissue
  5 deaths27 reports
• MOSAIC® 305C225

  Medtronic, Inc. · heart-valve, non-allograft tissue
  26 reports
• MITRIS RESILIA Mitral Valve 11400M

  Edwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue
  1 death26 reports