Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 1077...
FDA Device Recall #Z-2290-2025 — Class I — June 23, 2025
Recall Summary
| Recall Number | Z-2290-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | June 23, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Thoratec LLC |
| Location | Pleasanton, CA |
| Product Type | Devices |
| Quantity | 53 |
Product Description
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 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. The HeartMate II Left Ventricular Assist System 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. The LVAS may be used in any of two configurations. First, line power may be utilized through the Power Module or the Mobile Power Unit (MPU) to run the LVAD indefinitely, convenient for sedentary or sleeping periods. Second, portable Battery power may be utilized for limited periods, convenient for active periods. The MPU AC power cord is distributed either as part of the complete MPU device package or as a standalone accessory. (Labeling - Attachments E1 to E6) Component: Yes, the AC Power Cord is a component of the Mobile Power Unit
Reason for Recall
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Japan.
Lot / Code Information
Lot Code: US Model No 107760; UDI-DI 05415067038258, For Lot Numbers, see Attachment F.
Other Recalls from Thoratec LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1099-2026 | Class II | CentriMag Blood Pump, REF: 102953, 201-20003, 2... | Oct 10, 2025 |
| Z-0506-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate ... | Oct 9, 2025 |
| Z-0508-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate ... | Oct 9, 2025 |
| Z-0507-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate ... | Oct 9, 2025 |
| Z-0505-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate ... | Oct 9, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.