Edwards EVOQUE Tricuspid Delivery System Labelling Recall
Summary
Health Canada issued a Type II voluntary recall for Edwards EVOQUE Tricuspid Delivery System (Model 9850TDS) affecting all lots. This labeling correction does not require product return but is intended to update device labeling to support proper use and optimal performance. Healthcare providers using this device should review updated labeling materials.
What changed
Edwards Lifesciences LLC initiated a voluntary labeling correction for the Edwards EVOQUE Tricuspid Delivery System (Model 9850TDS), covering all lots. The recall, classified as Type II by Health Canada (Identification No. RA-81834), does not require product removal from the market. The correction addresses labeling updates necessary to support proper device use and optimal performance.
Healthcare providers using this tricuspid valve replacement system should review the updated labeling materials to ensure proper use. Contact the manufacturer at Edwards Lifesciences LLC (1 Edwards Way, Irvine, CA 92614) for additional information regarding the labeling changes. No product return is required under this recall.
What to do next
- Review updated device labeling for Edwards EVOQUE Tricuspid Delivery System
- Ensure all clinical staff are aware of labeling changes for proper device use
- Contact Edwards Lifesciences for additional information if needed
Archived snapshot
Apr 2, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
Edwards EVOQUE Tricuspid Delivery System
Brand(s)
Last updated
2026-04-02
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:
2026-04-02
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
2026-03-24
Identification number RA-81834
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Source
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Source document text, dates, docket IDs, and authority are extracted directly from Health Canada.
The plain-English summary, classification, and "what to do next" steps are AI-generated from the original text. Cite the source document, not the AI analysis.
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