FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Recall number
- Z-2172-2026
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Status
- Open, Classified
- Initiated
- 2026-03-27
- Posted
- 2026-05-13
- Terminated
- not on file
- Reason
- Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
- 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 xxxx@edwards.com. Electronic signatures may also be used, where available, to facilitate physician acknowledgment.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- All Lots/UDI:0690103D004EVD000V5
- 510(k) numbers
- not on file
- PMA numbers
- ["P230013"]
- Product code
- NPW
- Firm FEI
- 2015691
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28