Aortic Valve, Prosthesis, Percutaneously Delivered
FDA product code NPT · Class III (high risk) · Cardiovascular
To replace a patient's aortic heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
0510(k) clearances
8PMA approvals
33recalls
Implantimplanted device
PMA approvals
- P250024 Trilogy Transcatheter Heart Valve System · JenaValve Technology, Inc. · 03/17/2026
- P190023 Portico Transcatheter Aortic Valve Implantation System · Abbott Medical · 09/17/2021
- P180029 LOTUS Edge Valve System · Boston Scientific Corporation · 04/23/2019
- P140031 Sapien 3 Transcatheter Heart Valve and Accessories · Edwards Lifesciences, LLC · 06/17/2015
- P130009 Edwards Sapien XT Transcatheter Heart Valve and Accessories · Edwards Lifesciences, LLC · 06/16/2014
- P130021 Medtronic Corevalve System · Medtronic, Inc. · 01/17/2014
- P110021 Edwards Sapien Transcatheter Heart Valve and Accessories · Edwards Lifesciences, LLC · 10/19/2012
- P100041 Edwards Sapien Transcatheter Heart Valve and Accessories · Edwards Lifesciences, LLC · 11/02/2011
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0495-2025 Class II | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | Abbott Medical | 10/17/2024Open, Classified |
| Z-0494-2025 Class II | Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27…A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | Abbott Medical | 10/17/2024Open, Classified |
| Z-0493-2025 Class II | Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29…A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | Abbott Medical | 10/17/2024Open, Classified |
| Z-0492-2025 Class II | Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | Abbott Medical | 10/17/2024Open, Classified |
| Z-0491-2025 Class II | Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm…A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | Abbott Medical | 10/17/2024Open, Classified |
| Z-2043-2021 Class II | CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;Due to reports of actuator separation for various delivery catheter systems. Affected products were… | Medtronic Heart Valves Division | 06/11/2021Open, Classified |
| Z-2042-2021 Class II | CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;Due to reports of actuator separation for various delivery catheter systems. Affected products were… | Medtronic Heart Valves Division | 06/11/2021Open, Classified |
| Z-2041-2021 Class II | CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;Due to reports of actuator separation for various delivery catheter systems. Affected products were… | Medtronic Heart Valves Division | 06/11/2021Open, Classified |
| Z-0736-2021 Class I | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery…Failure to execute the visual inspection correctly prior to locking the valve during the deployment process… | Boston Scientific Corporation | 11/17/2020Terminated |
| Z-0735-2021 Class I | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery…Failure to execute the visual inspection correctly prior to locking the valve during the deployment process… | Boston Scientific Corporation | 11/17/2020Terminated |
| Z-0734-2021 Class I | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery…Failure to execute the visual inspection correctly prior to locking the valve during the deployment process… | Boston Scientific Corporation | 11/17/2020Terminated |
| Z-0730-2021 Class I | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery…Failure to execute the visual inspection correctly prior to locking the valve during the deployment process… | Boston Scientific Corporation | 11/17/2020Terminated |
| Z-0729-2021 Class I | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery…Failure to execute the visual inspection correctly prior to locking the valve during the deployment process… | Boston Scientific Corporation | 11/17/2020Terminated |
| Z-0728-2021 Class I | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery…Failure to execute the visual inspection correctly prior to locking the valve during the deployment process… | Boston Scientific Corporation | 11/17/2020Terminated |
| Z-0561-2021 Class II | Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as…Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon… | Medtronic Heart Valves Division | 10/23/2020Terminated |
| Z-0560-2021 Class II | Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as:…Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon… | Medtronic Heart Valves Division | 10/23/2020Terminated |
| Z-0559-2021 Class II | Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV…Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon… | Medtronic Heart Valves Division | 10/23/2020Terminated |
| Z-2227-2019 Class I | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)…The action has been initiated to address reports of burst balloons which have resulted in significant… | Edwards Lifesciences, LLC | 07/09/2019Terminated |
| Z-2226-2019 Class I | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)…The action has been initiated to address reports of burst balloons which have resulted in significant… | Edwards Lifesciences, LLC | 07/09/2019Terminated |
| Z-2225-2019 Class I | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)…The action has been initiated to address reports of burst balloons which have resulted in significant… | Edwards Lifesciences, LLC | 07/09/2019Terminated |
| Z-2224-2019 Class I | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)…The action has been initiated to address reports of burst balloons which have resulted in significant… | Edwards Lifesciences, LLC | 07/09/2019Terminated |
| Z-0835-2019 Class II | Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number…This action has been initiated to address complaint reports received for crimp balloon and inflation balloon… | Edwards Lifesciences, LLC | 01/22/2019Terminated |
| Z-2435-2018 Class II | Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mmSAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. | Edwards Lifesciences, LLC | 06/11/2018Terminated |
| Z-0293-2018 Class I | Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A…A component in the Certitude Loader may have a molding overflow defect that could detach during advancement… | Edwards Lifesciences, LLC | 07/21/2017Terminated |
| Z-2546-2016 Class II | Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and…Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). | Medtronic Cardiovascular Surgery-the Heart… | 08/03/2016Terminated |
| Z-2264-2015 Class I | EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C…Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. | Medtronic Cardiovascular Surgery-the Heart… | 07/15/2015Terminated |
| Z-0917-2015 Class I | Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System…Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion… | Boston Scientific Corporation | 11/19/2014Terminated |
| Z-0916-2015 Class I | Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System…Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion… | Boston Scientific Corporation | 11/19/2014Terminated |
| Z-0915-2015 Class I | Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System…Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion… | Boston Scientific Corporation | 11/19/2014Terminated |
| Z-3108-2017 Class II | On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the…Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. | CryoLife, Inc. | 02/12/2014Terminated |
| Z-0918-2014 Class II | Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN…Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they… | Edwards Lifesciences, LLC | 01/20/2014Terminated |
| Z-1135-2013 Class II | Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the…Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once… | Edwards Lifesciences, LLC | 03/26/2013Terminated |
| Z-1134-2013 Class II | Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the…Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once… | Edwards Lifesciences, LLC | 03/26/2013Terminated |