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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards EVOQUE tricuspid delivery system

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 Class 2 Device Recall Edwards EVOQUE tricuspid delivery systemsee related information
Date Initiated by FirmMarch 27, 2026
Date PostedMay 13, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2172-2026
Recall Event ID 98633
PMA NumberP230013 
Product Classification Percutaneously Delivered Prostheses and Tricuspid Valves - Product Code NPW
ProductEdwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Code Information All Lots/UDI:0690103D004EVD000V5
FEI Number 2015691
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information ContactBrian Hudson
949-250-6827
Manufacturer Reason
for Recall		Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
FDA Determined
Cause 2		Labeling design
ActionOn March 27, 2025, Edwards Lifesciences issued a Urgent: Medical Device Recall (Correction) Notification via mail. Edwards ask consignees to take the following actions: 1. There is no need to return any product and no patient follow-up or notification is necessary. 2. Please review this Urgent: Medical Device Recall (Correction) Notice . 3. Return the completed Customer Acknowledgment Form to your Edwards TMTT Representative or via email to xxxx@edwards.com. Electronic signatures may also be used, where available, to facilitate physician acknowledgment.
DistributionWorldwide - 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 the countries of Saudi Arabia, Germany, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = NPW
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