Class 2 Device Recall HeartMate

• Date Initiated by Firm: October 09, 2025
• Date Posted: November 14, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0506-2026
• Recall Event ID: 97782
• PMA Number: P160054
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 LVAS
• Code Information: Lot Code: All units of the following models are impacted: Model 106531US UDI: 05415067039446 Model 106531INT UDI: 05415067038982 Model 106531LF2 UDI: 05415067039422 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.
• Recalling Firm/ Manufacturer: Thoratec LLC; 6035 Stoneridge Dr; Pleasanton CA 94588-3270
• For Additional Information Contact: Ms. Shelley Lange; 1-612-3463514
• Manufacturer Reason for Recall: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
• FDA Determined Cause: Device Design
• Action: On 10/09/2025, the firm sent via email an "URGENT MEDICAL DEVICE RECALL (CORRECTION)" Letter to customers informing them that Abbott has observed an increase in customer complaints about the controller Backup Battery Fault Alarm. The issue is potentially due to excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller which results in corrosion of the ribbon cable connectors. What Customers should know: When the Backup Battery Fault Alarm is active, this Advisory alarm will appear as a flashing yellow wrench on the user interface and Call Hospital Contact; Backup Battery Fault will appear on the screen, accompanied by a slow beep tone. When in a clinical setting, the HeartMate Touch App will have an active alarm that reads Replace Backup Battery. As a reminder, when this alarm is active and the pump is running and flow is maintained (indicated by the green arrow symbol ), this alarm does not affect the controller or pump functionality. Customers are instructed: -When performing Backup Battery installation or replacement, clinicians should minimize excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller. An example of excessive handling would be using the ribbon cable to hold the weight of the controller. -Remind patients and caregivers to follow the Patient Handbook: If System Controller Backup Battery Fault Alarm is active, patients should first ensure that no other alarms are active, and then they should call their hospital contact as soon as possible for diagnosis and instructions. Patients and caregivers should not immediately attempt to exchange the System Controller without clinical guidance. For questions or further assistance is needed regarding the Backup Battery Alarm after following Instructions for Use, contact Abbott Technical Service at 1-800-456-1477 (Business hours: 8 AM EST to 7 PM EST).
• Quantity in Commerce: 35376
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = DSQ