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.
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
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.
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.
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.
Check for the reference number REF:9850TDS Sterile EO on the device packaging. The lot number 0690103D004EVD000V5 is also associated with this recall.
Review the device packaging for the reference number REF:9850TDS Sterile EO and lot number 0690103D004EVD000V5.
No, this recall is for labeling updates to ensure proper warnings if the valve replacement system is compromised. It does not pose an immediate safety risk.
Check the device packaging for the reference number REF:9850TDS Sterile EO and lot number 0690103D004EVD000V5. If you have these details, contact Edwards Lifesciences for labeling updates.
No, this recall does not require stopping use. It involves labeling updates to ensure clarity if the valve replacement system is compromised.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2172-2026 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2172-2026 from Edwards Lifesciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
