Artivion CryoValve SG Heart Valve Recall: Invalid Test Results

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Recalling firmArtivion, Inc1655 Roberts Blvd Nw · Kennesaw, GA 30144-3632

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Artivion is recalling specific CryoValve SG heart valves that were approved with invalid test results. This could lead to serious health risks if the valve is implanted.

Why it’s dangerous

The valves were approved and implanted using test results that were invalid. This means the valve may not function properly in the body, potentially causing serious health issues.

Who’s affected

Patients who received the recalled CryoValve SG heart valves (serial #11673489 or #12657716) are affected. Those with these specific valves are at highest risk.

How to tell if you have this one

Check for serial numbers 11673489 (expires Jan 27, 2026) or 12657716 (expires Aug 15, 2028) on the valve packaging or implant documentation.

Brand
Artivion
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using the valve if you have the recalled serial numbers.

✎ GovInfoNow

Questions people ask

Why is this valve being recalled?

The valves were approved and implanted with invalid test results, which could lead to serious health risks.

What serial numbers are affected?

Serial numbers 11673489 (expires Jan 27, 2026) and 12657716 (expires Aug 15, 2028).

Do I need to return the valve?

The recall record does not specify a return process, so contact your healthcare provider for guidance.

Take action

Contact Artivion

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

✉️ Open in email

Subject: Recall Z-2531-2024 — Artivion Artivion

Hello,

I own a Artivion that is covered by recall Z-2531-2024 from Artivion.

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.

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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-2531-2024 (May 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2531-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

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