Edwards EVOQUE Tricuspid Delivery System Recall: Labeling Update Warning
Edwards Lifesciences recalls EVOQUE tricuspid delivery system REF:985:0690103D004EVD000V5 due to potential labeling issues if valve replacement is compromised. Affected patients should check their device lot numbers.
Lower-risk recall
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Contact the company
What happened, in plain English
Edwards Lifesciences is recalling its EVOQUE tricuspid delivery system (REF:9850TDS Sterile EO) because labeling updates are needed if the valve replacement system is damaged. This recall doesn't pose an immediate safety risk but ensures proper labeling for device functionality. Read more at govinfonow.com/recall/49587-edwards-evoque-tricuspid-delivery-system-recall-labeling-update-warning.
Source Summary by GovInfoNow · govinfonow.com/recall/49587-edwards-evoque-tricuspid-delivery-system-recall-labeling-update-warning · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2172-2026
Cite this page
“Edwards EVOQUE Tricuspid Delivery System Recall: Labeling Update Warning.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49587-edwards-evoque-tricuspid-delivery-system-recall-labeling-update-warning. Based on FDA recall #Z-2172-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2172-2026%22&limit=1).
Why it’s dangerous
The recall involves labeling updates to warn users if the valve replacement delivery system is compromised. This ensures patients receive clear instructions if the device's functionality is affected, preventing potential misinterpretation of device status.
Who’s affected
Patients using the Edwards EVOQUE tricuspid delivery system with the specific reference number REF:9850TDS Sterile EO are affected. Those with the lot number 0690103D004EVD000V5 are most at risk.
How to tell if you have this one
Check for the reference number REF:9850TDS Sterile EO on the device packaging. The lot number 0690103D004EVD000V5 is also associated with this recall.
- Brand
Edwards Lifesciences- Category
Medical device
What to do — step by step
Check Device Labeling
Review the device packaging for the reference number REF:9850TDS Sterile EO and lot number 0690103D004EVD000V5.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 42 states.
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2172-2026 (March 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2172-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.