Edwards recalls SAPIEN 3 Transcatheter Heart Valve (Model 960: 26mm) due to incorrect valve size packaging. Affected units have specific serial numbers and use-by dates.
“Edwards SAPIEN 3 Heart Valve Recall: Incorrect Size Packaging.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70861-edwards-sapien-3-heart-valve-recall-incorrect-size-packaging. Based on FDA recall #Z-2435-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2435-2018%22&limit=1).
Edwards Lifesciences, LLC voluntarily recalled one Edwards SAPIEN 3 Transcatheter Heart Valve on June 11, 2018, according to the FDA. The device was packaged with an incorrect valve size relative to its label.
The SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Context
GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since 2017-07-06. Other recent recalls of similar products include Edwards EVOQUE Tricuspid Delivery System Recall (2026-03-27), Edwards FEM-FLEX II Femoral Arterial Cannula Recall (2025-05-14), and Edwards Lifesciences TruWave Vamp Pressure Monitoring Set Recall (2023-10-04). Other recent recalls of similar products include Bard Ureteral Stent Kit Recall (2025-11-06), On-X Mitral Heart Valve Recall (2026-02-01), and EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (2026-02-16).
How to tell if you have this one
Check for the model number 9600TFX, size 26 mm, and use-by date January 24, 2020. Serial numbers starting with 6005731 are affected.
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-2435-2018 (June 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2435-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.