Reported Nov 26, 2025 · Ongoing
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS…
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 II¿
- LVAS Implant Kit Model/Catalog Number106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed
- EU Software VersionN/A
- Product DescriptionThe HeartMate II LVAS is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries
- ComponentNo
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published — Lot Code: All units of the following models are impacted 10601500813024011224UDI: 00813024011224 10601600813024011231UDI: 00813024011231 Note: Product bracketing is determined based on possible use of the controller. Since the backup battery has a 3 year life cycle, it can be replaced (per the IFU) and the controller will continue to be used. - Amount recalled
- 248
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
This product could cause temporary or reversible health problems — stop using it.
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