Mitral Valve Repair Devices
FDA product code NKM · Class III (high risk) · Cardiovascular
To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.
0510(k) clearances
2PMA approvals
6recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2479-2023 Class II | PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000ISDue to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or… | Edwards Lifesciences, LLC | 07/27/2023Open, Classified |
| Z-0117-2023 Class II | Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW…An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been… | Abbott Vascular | 09/08/2022Open, Classified |
| Z-0116-2023 Class II | Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip…An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been… | Abbott Vascular | 09/08/2022Open, Classified |
| Z-0115-2023 Class II | Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip…An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been… | Abbott Vascular | 09/08/2022Open, Classified |
| Z-1687-2019 Class II | Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR…Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional… | Abbott Vascular | 05/01/2019Terminated |
| Z-0911-2016 Class I | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains…Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the… | Abbott Vascular | 02/04/2016Terminated |