Heart-Valve, Mechanical

FDA product code LWQ · Class 3 · 198 devices · 1,386 reports · 133 deaths reported · 1 devices named in recalls

• On-X Mitral Heart Valve with Conform-X Sewing Ring ONXMC-25/33

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  1 recall1 death34 reports
• SJM Regent™ AGFN-756

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 deaths70 reports
• SJM Regent™ AGFN-756

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  5 deaths66 reports
• SJM Regent™ 23AGFN-756

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 deaths44 reports
• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-021

  Corcym Srl · HEART-VALVE, MECHANICAL
  7 deaths37 reports
• Regent™ 21AGFN-756

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 deaths35 reports
• Regent™ 23AGFN-756

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  2 deaths33 reports
• Regent™ 19AGFN-756

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  31 reports
• On-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder ONXACE-23

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  2 deaths28 reports
• On-X Ascending Aortic Prosthesis ONXAAP-25

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  2 deaths25 reports
• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-023

  Corcym Srl · HEART-VALVE, MECHANICAL
  6 deaths25 reports
• SJM Regent™ 25AGFN-756

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  2 deaths23 reports
• SJM™ Masters Series HP Gelweave Valsalva 25VAVGJ-515

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  2 deaths23 reports
• SJM Regent™ 19AGN-751

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 deaths22 reports
• On-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder ONXACE-21

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  21 reports
• SJM™ Masters Series 27MJ-501

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  1 death21 reports
• SJM™ Masters Series HP Gelweave Valsalva 23VAVGJ-515

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 deaths20 reports
• SJM™ Masters Series 29MJ-501

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 deaths18 reports
• On-X Mitral Heart Valve with Standard Sewing Ring ONXM-25

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  6 deaths17 reports
• On-X Ascending Aortic Prosthesis ONXAAP-23

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  2 deaths17 reports
• SJM Regent™ 21AGN-751

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  17 reports
• SJM™ Masters Series HP Gelweave Valsalva 27VAVGJ-515

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  17 reports
• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-025

  Corcym Srl · HEART-VALVE, MECHANICAL
  2 deaths17 reports
• CARBOMEDICS OPTIFORM F7-027

  Corcym Srl · HEART-VALVE, MECHANICAL
  3 deaths16 reports
• On-X Mitral Heart Valve with Standard Sewing Ring ONXM-27/29

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  3 deaths15 reports
• On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder ONXANE-23

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  2 deaths15 reports
• CARBOMEDICS STANDARD M7-027

  Corcym Srl · HEART-VALVE, MECHANICAL
  2 deaths15 reports
• SJM™ Masters Series 27MECJ-502

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 deaths14 reports
• Open Pivot™ 505DA20

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  1 death13 reports
• Masters Series™ 27MJ-501

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  1 death13 reports
• CARBOMEDICS REDUCED R5-021

  Corcym Srl · HEART-VALVE, MECHANICAL
  13 reports
• On-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder ONXACE-25

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  12 reports
• On-X Ascending Aortic Prosthesis ONXAAP-27/29

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  1 death12 reports
• CARBOMEDICS STANDARD M7-025

  Corcym Srl · HEART-VALVE, MECHANICAL
  1 death12 reports
• CARBOMEDICS OPTIFORM F7-029

  Corcym Srl · HEART-VALVE, MECHANICAL
  12 reports
• Open Pivot™ 500DM29

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  11 reports
• SJM™ Masters Series 29MECJ-502

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  11 reports
• CARBOMEDICS STANDARD A5-023

  Corcym Srl · HEART-VALVE, MECHANICAL
  11 reports
• SJM™ Masters Series HP Gelweave Valsalva 21VAVGJ-515

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  2 deaths10 reports
• CARBOMEDICS REDUCED R5-023

  Corcym Srl · HEART-VALVE, MECHANICAL
  2 deaths10 reports
• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-019

  Corcym Srl · HEART-VALVE, MECHANICAL
  4 deaths10 reports
• CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-027

  Corcym Srl · HEART-VALVE, MECHANICAL
  2 deaths10 reports
• Open Pivot™ 505DA24

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  1 death9 reports
• On-X Mitral Heart Valve with Standard Sewing Ring ONXM-31/33

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  2 deaths9 reports
• SJM Regent™ 23AGN-751

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  9 reports
• SJM™ Masters Series 21AECJ-502

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  1 death9 reports
• Masters Series™ 29MJ-501

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  2 deaths9 reports
• CARBOMEDICS STANDARD A5-025

  Corcym Srl · HEART-VALVE, MECHANICAL
  9 reports
• CARBOMEDICS STANDARD M7-031

  Corcym Srl · HEART-VALVE, MECHANICAL
  9 reports
• CARBOMEDICS REDUCED R5-025

  Corcym Srl · HEART-VALVE, MECHANICAL
  9 reports
• Open Pivot™ 500DM27

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  1 death8 reports
• SJM™ Masters SeriesHemashield™ 25CAVGJ-514 00

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  8 reports
• SJM™ Masters Series 25MJ-501

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  8 reports
• SJM™ Masters Series 15MHPJ-505

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  2 deaths8 reports
• Regent™ 21AGN-751

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  8 reports
• CARBOMEDICS STANDARD M7-029

  Corcym Srl · HEART-VALVE, MECHANICAL
  8 reports
• Open Pivot™ 505DA18

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  7 reports
• SJM™ Masters SeriesHemashield™ 27CAVGJ-514 00

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  1 death7 reports
• SJM™ Masters Series 31MJ-501

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  7 reports
• SJM™ Masters Series HP Gelweave Valsalva 29VAVGJ-515

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  7 reports
• CARBOMEDICS CARBO-SEAL VALSALVA CP-025

  Corcym Srl · HEART-VALVE, MECHANICAL
  1 death7 reports
• On-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder ONXACE-19

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  1 death6 reports
• On-X Ascending Aortic Prosthesis ONXAAP-21

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  6 reports
• On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder ONXANE-19

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  6 reports
• SJM™ Masters Series 25MECJ-502

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  1 death6 reports
• SJM™ Masters Series 31MECJ-502

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  6 reports
• SJM™ Masters Series AJ-501

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  2 deaths6 reports
• SJM™ Masters Series 19AECJ-502

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  6 reports
• Masters Series™ 31MJ-501

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  6 reports
• CARBOMEDICS CARBO-SEAL VALSALVA CP-023

  Corcym Srl · HEART-VALVE, MECHANICAL
  1 death6 reports
• Open Pivot™ 505DA20

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  5 reports
• Open Pivot™ 505DA22

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  5 reports
• Open Pivot™ 500DM33

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  1 death5 reports
• Open Pivot™ 505DA22

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  5 reports
• Open Pivot™ 500DM25

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  1 death5 reports
• On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder ONXAE-25

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  5 reports
• On-X Aortic Heart Valve with Conform-X Sewing Ring ONXACE-27/29

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  1 death5 reports
• SJM™ Masters Series HP 19AHPJ-505

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 deaths5 reports
• SJM™ Masters Series 15AHPJ-505

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  1 death5 reports
• Masters Series™ 21AHPJ-505

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  5 reports
• CARBOMEDICS STANDARD A5-021

  Corcym Srl · HEART-VALVE, MECHANICAL
  5 reports
• CARBOMEDICS STANDARD M7-033

  Corcym Srl · HEART-VALVE, MECHANICAL
  5 reports
• CARBOMEDICS CARBO-SEAL VALSALVA CP-029

  Corcym Srl · HEART-VALVE, MECHANICAL
  2 deaths5 reports
• Open Pivot™ 500DM27

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  4 reports
• Open Pivot™ 505DM26

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  2 deaths4 reports
• On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder ONXAE-19

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  1 death4 reports
• On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder ONXAE-21

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  1 death4 reports
• On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder ONXAE-23

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  2 deaths4 reports
• On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder ONXAE-27/29

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  1 death4 reports
• On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder ONXANE-21

  On-X Life Technologies, Inc. · Heart-Valve, Mechanical
  2 deaths4 reports
• SJM™ Masters SeriesHemashield™ 21CAVGJ-514 00

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  4 reports
• SJM™ Masters SeriesHemashield™ 23CAVGJ-514 00

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  4 reports
• CARBOMEDICS REDUCED R5-019

  Corcym Srl · HEART-VALVE, MECHANICAL
  4 reports
• CARBOMEDICS OPTIFORM F7-025

  Corcym Srl · HEART-VALVE, MECHANICAL
  4 reports
• CARBOMEDICS CARBO-SEAL VALSALVA CP-027

  Corcym Srl · HEART-VALVE, MECHANICAL
  4 reports
• Open Pivot™ 500DM31

  Medtronic, Inc. · HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series HP 17AHPJ-505

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series HP 21AHPJ-505

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series HP 23AHPJ-505

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series 23MECJ-502

  St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL
  3 reports