FDA & Regulatory
Recalls, PMA approvals, and adverse events for heart valve devices
6 events
PMA ApprovalJun 22, 2026
FDA PMA: Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valvesCompany: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
PMA ApprovalJun 11, 2026
FDA PMA: Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)Company: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
PMA ApprovalMay 28, 2026
FDA PMA: AmplatzerTM PFO Occluder; AmplatzerTM Talisman PFO OccluderCompany: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
PMA ApprovalMay 28, 2026
FDA PMA: AmplatzerTM Septal Occluder; AmplatzerTM Multifenestrated Septal Occluder - CribriformCompany: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
PMA ApprovalMay 28, 2026
FDA PMA: AmplatzerTM Muscular VSD OccluderCompany: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
RecallMay 25, 2026
Recall: Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, SterileCompany: Abbott Medical
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impact...