HeartMate 11V Backup Battery Recall: Battery Failures Risk

Take action

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 11V Li-ion Backup Battery model 106128 because it can fail, potentially causing power loss in the HeartMate system controller. This could affect the device's emergency power function if the main power source fails.

Why it’s dangerous

The battery powers the HeartMate system controller during power outages. If it fails, the emergency power function may not work, risking loss of critical system monitoring and alarms.

Who’s affected

HeartMate 3" System Controller users with the specific battery model 106128 are affected. Those relying on the emergency power function are at higher risk.

How to tell if you have this one

Check for the model number 106128 on the battery. The battery is part of the HeartMate 3" System Controller and has a serial number listed in Attachment E for US distribution.

Brand
HeartMate
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Battery Model
Look for model number 106128 on the battery to confirm it is recalled.

✎ GovInfoNow

Questions people ask

What is the hazard with this battery?

The battery can fail, potentially causing loss of emergency power during system outages.

How do I know if I have the recalled battery?

Check for model number 106128 on the battery; serial numbers are listed in Attachment E for US distribution.

What should I do if I have the recalled battery?

The recall record does not specify a remedy, so contact Thoratec for guidance.

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-2520-2026 — HeartMate HeartMate

Hello,

I own a HeartMate that is covered by recall Z-2520-2026 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.

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-2520-2026 (May 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2520-2026 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: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version:

Recall notice