Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The 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. Component: No

Due to 11 volt Backup Battery failures.

On 05/13/2026, the firm sent email an "URGENT MEDICAL DEVICE RECALL" Letter informing customers that As of April 27, 2026, Abbott received twenty-four (24) complaints where an advisory warning, Replace Backup Battery, was triggered once certain 11V Backup Batteries were connected to the System Controller. This warning is displayed as a yellow banner on the HeartMate Touch Monitor and System Monitor. This advisory alert is only visible when using HeartMate Touch or the System Monitor in the clinic, it is not visible to the patient. Customers are instructed to: 1. Read this notification thoroughly, complete and sign the form included with this letter, acknowledging that you received and understand this information, and that you will communicate this information to those relevant in your facility. Once complete, return the acknowledgement form to Abbott. 2. Use the online lookup tool (https://www.cardiovascular.abbott/us/en/hcp/product-advisories/heartmatebatteries-2026.html) to confirm if a 11V Lithium-Ion battery at your site is an impacted one. Figure 3 shows an instruction on how to locate the serial numbers of the impacted batteries. 3. Once the impacted batteries are identified, do not use them. 4. Beginning May 15, 2026, a separate email will be sent to your site confirming shipment of replacement batteries. This email will include return shipping labels and a device retrieval form, along with detailed instructions for returning the affected batteries. For Questions - contact your Abbott representative or Abbott Technical Support at 1-800-456-1477 (Business hours: 8 AM EST to 7 PM EST).