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:

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

MitraClip XTR Clip Delivery System

Lot or serial number

Not applicable.

Model or catalog number

CDS0602-XTR

Companies
Manufacturer
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES