Health product recall

Mitraclip/Triclip G4 Delivery Systems

Brand(s)
Last updated

Summary

Product
Mitraclip/Triclip G4 Delivery Systems
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Mitraclip G4 Clip Delivery System, Nt

More than 10 numbers, contact manufacturer.

CDS0701-NT

Triclip G4 Delivery System

More than 10 numbers, contact manufacturer.

TCDS0305-XTW
TCDS0305-XT
TCDS0305-NT
TCDS0305-NTW

Mitraclip G4 Clip Delivery System, Ntw

More than 10 numbers, contact manufacturer.

CDS0701-NTW

Mitraclip G4 Clip Delivery System, Xtw

More than 10 numbers, contact manufacturer.

CDS0701-XTW

Mitraclip G4 Clip Delivery System, Xt

More than 10 numbers, contact manufacturer.

CDS0701-XT

Issue

Abbott has observed an increase in complaints regarding clip locking malfunctions. Abbott is bringing awareness and taking action to emphasize the relevant steps of the instructions for use (IFU) to aid in optimal function of the clip locking mechanism. Current inventory of product may be used with the guidance described in the attached materials. There is no need to return any product to abbott. no further action is needed for patients who have had clips previously implanted.  The increased rate of reports is for clips failing to "establish final arm angle" (EFAA) and for events of "clip opening while locked" (COWL).

Recall start date: September 8, 2022

Additional information

Details
Original published date: 2022-09-26
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

Abbott Vascular

3200 Lakeside Drive, Santa Clara, California, United States, 95054-2807

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64557