Home › Device types › NKM
Mitral Valve Repair Devices
FDA product code NKM · Class 3 · Unknown
21
Registered devices
25,400
Adverse events
6
Recalls
0
510(k) clearances
Devices with this code
MitraClip™ — ST. JUDE MEDICAL, INC.MitraClip™ — ST. JUDE MEDICAL, INC.MITRACLIP — ABBOTT VASCULAR INC.PASCAL — Edwards Lifesciences LLCMITRACLIP — ABBOTT VASCULARMitraClip™ — ST. JUDE MEDICAL, INC.MITRACLIP — ABBOTT VASCULAR INC.MITRACLIP — ABBOTT VASCULAR INC.MitraClip™ — ST. JUDE MEDICAL, INC.PASCAL — Edwards Lifesciences LLCMitraClip™ — ST. JUDE MEDICAL, INC.PASCAL PRECISION — Edwards Lifesciences LLCMitraClip™ — ST. JUDE MEDICAL, INC.MitraClip™ — ST. JUDE MEDICAL, INC.MITRACLIP — ABBOTT VASCULAR INC.MITRACLIP — ABBOTT VASCULAR INC.MITRACLIP — ABBOTT VASCULAR INC.MITRACLIP — ABBOTT VASCULAR INC.MitraClip™ — ST. JUDE MEDICAL, INC.PASCAL — Edwards Lifesciences LLCPASCAL — Edwards Lifesciences LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-27 | Edwards Lifesciences, LLC | Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when |
| 2022-09-08 | Abbott Vascular | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking c |
| 2022-09-08 | Abbott Vascular | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking c |
| 2022-09-08 | Abbott Vascular | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking c |
| 2019-05-01 | Abbott Vascular | Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied durin |
| 2016-02-04 | Abbott Vascular | Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting |
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