Health product recall

Edwards EVOQUE Tricuspid Delivery System

Last updated

Summary

Product
Edwards EVOQUE Tricuspid Delivery System
Issue
Medical devices - Labelling and packaging
What to do

​​​​​Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Edwards EVOQUE Tricuspid Delivery System All lots. 9850TDS

Issue

Edwards Lifesciences is notifying customers of a voluntary recall (correction) involving a labeling update for the Edwards EVOQUE Tricuspid Valve Replacement System. This recall does not require product return but rather is intended to make a correction to the device labeling to support proper use of the device and help ensure optimal performance.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Obstetrics and gynaecology
Companies

Edwards Lifesciences LLC

1 Edwards Way, Irvine, California, United States, 92614

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81834

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