Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿
Summary
The FDA issued a Class II for Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Mode by Thoratec LLC. Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm..
Details
Source
Device Recall
External ID
Z-0508-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The 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. Component: Yes, HeartMate II¿ LVAS Implant Kit
Lot/Code Info: Lot Code: All units of the following models are impacted: Model 106017 UDI: 00813024011248 Model 106762 UDI: 00813024011286 Model 107801 UDI: 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.
Quantity Affected: 2424
Reason for Recall
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Algeria, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, Uzbekistan.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-09
Company
Pleasanton, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 222 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Thoratec LLC has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Thoratec LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Thoratec LLC have FDA actions?
Thoratec LLC has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0508-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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