CanadaThe Edwards EVOQUE Tricuspid Delivery System (model/catalogue 9850TDS, all lots) is affected. Edwards Lifesciences is voluntarily correcting the device labeling to support proper use and help ensure optimal performance; the recall does not require product return. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Edwards Lifesciences LLC, 1 Edwards Way, Irvine, California, United States, 92614.
How to identify it
Affected products: Edwards EVOQUE Tricuspid Delivery System; Lot or serial number: All lots.; Model or catalogue number: 9850TDS
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)