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HeartMate recallZ-1570-2025 · Thoratec LLC · initiated Mar 13, 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

Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.

FDA root cause category: Process control

What the company is doing

On 3/13/2025, recall notices were sent to customers who were asked to do the following: If patients are/ and are not able to be identified using the serial number list, send those patients the patient letter. If the MPU is not listed, this device is not affected. For units in use that have experienced MPU power issues: If there is an MPU power failure, transfer the patient from the MPU to the 14V rechargeable batteries within 15 minutes (see IFU). The Backup Battery in the System Controller will temporarily power the pump during a power source switch for up to 15 minutes. MPU will continue to echo the controller alarms as long as the internal AA batteries in the MPU do not need replacement. Do not continue to use the MPU and contact firm's Technical Support at 1-800-456-1477 (8 AM EST to 7 PM EST) for return and replacement. For units in use but not experiencing MPU power issues: Provide patient letter and educate about the issue. Ensure the patient's 14V rechargeables are ready and available for use. Prompt patient to replace AA batteries inside the MPU immediately if the Yellow Mobile Power Unit Battery Indicator alarm is active. Firm will replace these with new units starting June 2025. Return/replace units not distributed, not in use, on shelves, or that are unopened. Contact Customer Support at 1-612-444-3013, Option 2 (9 AM EST to 6:30 PM EST). Complete/return the acknowledgement form via email to [email protected] Distribute this notice to those who need to be aware within your institution and to any organization to which these devices may have been transferred. Device lookup tool with the impacted MPU devices, available by March 24th, 2025: https://www.cardiovascular.abbott/us/en/hcp/products/heart-failure/left-ventricular-assistdevices/ heartmate-3/indications-safety-warnings/advisories.html by March 24th, 2025. If you have questions, contact Technical Support.

Recall details

Recall number
Z-1570-2025
Status
Open, Classified
Initiated by the company
Mar 13, 2025
Posted by the FDA
Apr 17, 2025
Recalling firm
Thoratec LLC
Quantity
1661
Product code
DSQ
FDA submissions
P160054, P060040
Distribution
Worldwide - US Nationwide distribution in the states of WA, NE, VA, PA, DC, KY, CA, IL, WI, TX, MA, AR, MS, MI, OH, FL, NC, TN, LA, NJ, UT, NY, DE, CT, GA, IN, AZ, OK, MO, OR, MN, SC, NM, MD, IA, KS, AL, CO, ME and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CZECH REPUBLIC, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, ISRAEL, ITALY, JAPAN, KUWAIT, LEBANON, LITHUANIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, ROMANIA, SERBIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UK, UNITED ARAB EMIRATES.

Product description

HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.

Code information (models, lots, serial numbers)

Show the full code information (17k characters)

UDI-DI: 05415067038234. MPUs distributed between April 2024 and February 2025. 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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.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page