Reported Nov 26, 2025 · Ongoing
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿…
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¿ Controller (standalone)
- Model/Catalog Number106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿
- Pocket Controller Software VersionN/A
- Product DescriptionThe HeartMate II System Controller is a small computer that controls and monitors system operation. It sends power and operating signals to the Left Ventricular Assist Device and adjusts device operation to maintain programmed levels of cardiac support. The System Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records device performance and alarm data, and transfers the information to the HeartMate Touch Communication System
- ComponentYes, HeartMate II¿ LVAS Implant Kit
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published — Lot Code: All units of the following models are impacted 10601700813024011248UDI: 00813024011248 10676200813024011286UDI: 00813024011286 10780100813024011996UDI: 00813024011996 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
- 2424
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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