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# Abbott Class 1 Recall of MitraClip Delivery System
- URL: https://www.fdaweb.com/abbott-class-1-recall-of-mitraclip-delivery-system/
- Published: 2016-02-29T12:00:00.000Z
- Updated: 2026-09-15T02:39:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134903

> Abbott has begun a Class 1 recall of its MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company says it has received nine Medical Device Reports where the user was unable to separate the implantable Clip from the delivery system. “Abbott’s investigation determined that the delivery system’ ‘arm positioner’ was not returned to the required neutral position by the operator during the deployment sequence, subsequently preventing the Clip from detaching,” a [recall notice](http://www.fda.gov/Safety/Recalls/ucm488133.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “All of these cases (0.17% incidence) resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem. There was one patient death in these cases as a result of severe comorbidities following surgery.”  
>  
> The MitraClip Delivery System is used to treat people with degenerative mitral regurgitation (DMR) a condition involving a dysfunction of the heart's mitral valve. The recall applies to a company-generated safety notice and the device is not being removed from commercial distribution. Abbott is requiring training of all MitraClip implanting physicians on the safety notice, and it is incorporating the safety notice’s deployment sequence in the device’s instructions for use.