HeartMate 3 System Controller Recall: Backup Battery Failures Risk

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Contact the company & request your remedy

Recalling firmThoratec LLC6035 Stoneridge Dr · Pleasanton, CA 94588-3270

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Thoratec is recalling HeartMate 3 System Controllers with model number 106531US because their backup batteries may fail. This could lead to system shutdowns or other issues if the device loses power unexpectedly.

Why it’s dangerous

The backup battery in the HeartMate 3 System Controller may fail, causing the device to lose power unexpectedly. This could lead to system shutdowns or other issues if the device loses power unexpectedly.

Who’s affected

Users of the HeartMate 3 LVAS system who own the recalled controller model 106531US are affected. Patients with implanted left ventricular assist devices are most at risk.

How to tell if you have this one

Check for the model number 106531US on the HeartMate 3 System Controller. The product was sold in the US with specific serial numbers listed in Attachment E.

Brand
HeartMate
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Controller Model
Identify the model number on the controller, which should be 106531US for affected units.
Contact Manufacturer
Reach out to Thoracec LLC for further instructions on the recall remedy.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to potential failures in the 11-volt backup battery, which could cause unexpected system shutdowns.

How can I tell if my controller is affected?

Check for the model number 106531US on the controller. The product was sold in the US with specific serial numbers listed in Attachment E.

What should I do if I have the affected controller?

Contact Thoracec LLC for further instructions on the recall remedy.

Take action

Contact HeartMate

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

✉️ Open in email

Subject: Recall Z-2519-2026 — HeartMate HeartMate

Hello,

I own a HeartMate that is covered by recall Z-2519-2026 from HeartMate.

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-2519-2026 (May 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2519-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.

Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A

Lower-risk recall