Edwards SAPIEN 3 Heart Valve Recall: Incorrect Size Packaging

Take action

Contact the company & request your remedy

Recalling firmEdwards Lifesciences, LLC1 Edwards Way · Irvine, CA 92614-5688

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Edwards is recalling SAPIEN 3 Transcatheter Heart Valve (Model 9600TFX, 26mm) because it was shipped with the wrong valve size label. This could lead to improper valve fitting during surgery, risking complications for patients.

Why it’s dangerous

The valve was packaged with the incorrect size label compared to what's on the product. This means the valve might not fit properly during surgery, potentially causing complications like improper function or rejection.

Who’s affected

Patients who received this specific heart valve model during surgery are affected. Medical teams using the valve for procedures are most at risk.

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.

Brand
Edwards
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Valve Label
Verify the valve size label matches the model number and size on the product packaging.

✎ GovInfoNow

Questions people ask

Is this valve dangerous if used correctly?

No, the hazard is only in the packaging error, not the valve itself. The valve is safe if used with the correct size label.

How can I tell if my valve is affected?

Check for model 9600TFX, size 26 mm, use-by date January 24, 2020, and serial numbers starting with 6005731.

Do I need to return this valve?

The recall does not specify a return process, so contact Edwards Lifesciences directly for guidance.

Take action

Contact Edwards

We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2435-2018 — Edwards Edwards

Hello,

I own a Edwards that is covered by recall Z-2435-2018 from Edwards.

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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Where this comes from

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.

Edwards Lifesciences, LLC recalls Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm

Lower-risk recall