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MITRACLIP
ABBOTT VASCULAR INC. · Model CDS0601-XTR · UDI-DI 08717648226366
NKM
Prescription
0
510(k) clearances
25,635
Adverse events (1,786 deaths)
6
Recalls
19
Facilities
Description
MitraClip XTR Clip Delivery System
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 attempting to relea |
| 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 component material pr |
| 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 component material pr |
| 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 component material pr |
| 2019-05-01 | Abbott Vascular | Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantat |
| 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 a MitraClip, but the |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.