Reported Jun 24, 2026 · Ongoing
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US…
Thoratec LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thoratec LLC · 6035 Stoneridge Dr · Pleasanton, CA · 94588-3270
Is this the product you have?
- Brand NameHeartMate
- Product NameHeartMate 3 Left Ventricular
- System (LVAS) Kits Model/Catalog Number106524US
- Software VersionN/A
- Product DescriptionThe HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit
- ComponentNo
- Lot codes and dates
- Lot CodeModel
- Number106524US UDI/GTIN 05415067039323
- Serial Numbers Distributed in USSee Attachment E for serial numbers distributed
- Amount recalled
- 4
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to 11 volt Backup Battery failures.
This product could cause temporary or reversible health problems — stop using it.
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