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HeartMate recallZ-2291-2025 · Thoratec LLC · initiated Jun 23, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Thoratec LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Vendor change control

What the company is doing

Customer advisory letters dated June 23, 2025, will be hand delivered and by email to all impacted consignees. The customer advisory letters will be posted on the Abbott Product Advisory website for further visibility. As stated in the customer letter, affected AC Power Cords from US and OUS consignees and patient units that are experiencing connection issues will be returned and replaced. Instruction to Customers: Refer to "User Action Requested" section in attached customer letter for instructions to consignees. (Attachment D1, D2, and D3)

Recall details

Recall number
Z-2291-2025
Status
Open, Classified
Initiated by the company
Jun 23, 2025
Posted by the FDA
Aug 13, 2025
Recalling firm
Thoratec LLC
Quantity
604
Product code
DSQ
FDA submissions
P160054, P060040
Distribution
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.

Product description

Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 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. Component: Yes, the MPU is a component of the HeartMate 3 and HeartMate II Left Ventricular Assist Systems.

Code information (models, lots, serial numbers)

Lot Code: US Model No 107754; UDI-DI 05415067038234 Serial Numbers, see Attachment F.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

24 devices cleared under P160054, P060040 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97256).

Sources and updates

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