Public recall detail

Edwards EVOQUE Tricuspid Delivery System

2026-04-02

medium
Obstetrics and gynaecology Labelling and packaging
Quick summary

Quick summary: Edwards EVOQUE Tricuspid Delivery System. Reason: Labelling and packaging. Category: Obstetrics and gynaecology. Date: 2026-04-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Edwards EVOQUE Tricuspid Delivery System. Reason: Labelling and packaging. Category: Obstetrics and gynaecology. Date: 2026-04-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandEdwards Lifesciences LLC
ProductEdwards EVOQUE Tricuspid Delivery System
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-81834

Affected products

ProductEdwards EVOQUE Tricuspid Delivery System
LotAll lots.
Model9850TDS
Serial numberAll lots.
DescriptionEdwards EVOQUE Tricuspid Delivery System

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.

What you should do

  • ​​​​​Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Obstetrics and gynaecology
CompaniesEdwards Lifesciences LLC 1 Edwards Way, Irvine, California, United States, 92614
Recall date2026-03-24
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81834
Background{}
CompaniesEdwards Lifesciences LLC 1 Edwards Way, Irvine, California, United States, 92614
AudiencesHealthcare
Source updated2026-04-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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