Z-2172-2026Class II

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Name: Z-2172-2026 Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Creator: Edwards Lifesciences, LLC
Published: 2026-03-27
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2026-03-27 / Open, Classified / root cause: labeling and UDI

FDA source

Edwards Lifesciences, LLC began a recall of Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO on 2026-03-27. FDA classified it as Class II and gives the reason as "Labeling update to provide warning if functionality of the valve replacement delivery system is compromised". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2172-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-27
Posted: 2026-05-13
Recalling firm: Edwards Lifesciences LLC
Product: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Product code: NPW Percutaneously Delivered Prostheses And Tricuspid Valves
Reason for recall: Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 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 [email protected]. Electronic signatures may also be used, where available, to facilitate physician acknowledgment.
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 the countries of Saudi Arabia, Germany, United Kingdom.
Product codes and lots: All Lots/UDI:0690103D004EVD000V5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2172-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2172-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-13

Product code NPW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)