SynCardia Total Artificial Heart System Recall: Tears in Cannula Risk

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Recalling firmSynCardia Systems LLC1992 E Silverlake Rd, N/A · Tucson, AZ 85713-3865

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

SynCardia is recalling two models of total artificial heart systems because tears in the cannula have been reported due to wear and tear stress. This could lead to complications if the cannula fails during use.

Why it’s dangerous

Tears in the cannula can occur due to normal wear and tear stress over time. This could potentially cause complications if the cannula fails during use, but the risk is not immediate or severe.

Who’s affected

Patients with a SynCardia Total Artificial Heart System (70CC model 500101-001 or 50CC model 570500-000) are affected. Those with these specific models are most at risk.

How to tell if you have this one

Check for the model numbers 500101-001 (70CC) or 570500-000 (50CC) on your SynCardia Total Artificial Heart System. These models were sold by SynCardia Systems LLC.

Brand
SynCardia
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for the model numbers 500101-001 (70CC) or 570500-000 (50CC) on your device.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The recall is due to reported tears in the cannula from wear and tear stress.

What should I do if I have this model?

The official notice does not specify a remedy, so check with SynCardia Systems LLC for further instructions.

Is there a risk of serious injury?

The hazard description mentions tears from wear and tear stress, but does not indicate a risk of serious injury in normal use.

Take action

Contact SynCardia

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

✉️ Open in email

Subject: Recall Z-1022-2023 — SynCardia SynCardia

Hello,

I own a SynCardia that is covered by recall Z-1022-2023 from SynCardia.

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-1022-2023 (November 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1022-2023 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.

SynCardia Systems LLC recalls SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

Lower-risk recall