MitraClip XTR Clip Delivery System (2019-04-30)

Starting date:

April 30, 2019

Posting date:

May 14, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69938

Last updated: 2019-05-14

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  Reason
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  Affected products

Affected Products

MitraClip XTR Clip Delivery System

Reason

Abbott has confirmed reports of XTR Clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied to the clip during implantation. Once the clip becomes nonfunctional, the inability to close and remove the device has led to surgery or additional intervention.

Affected products