Thoratec HeartMate Mobile Power Unit Recall: Electrical Issues May Cause Unintended
Thoratec recalls HeartMate Mobile Power Units (MPUs) with serial numbers from 20226263 to 20307999. These units may experience electrical issues causing unintended shutdowns or alarms. If power is lost, the system may run for up to 15 minutes before stopping. Affected units were distributed between April 2024 and February 2025.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Thoratec is recalling HeartMate Mobile Power Units (MPUs) that may have electrical issues causing unintended shutdowns or alarms. If the unit loses power, the system can run for up to 15 minutes before stopping. This could be dangerous for patients using left ventricular assist systems. Read more at govinfonow.com/recall/52635-thoratec-heartmate-mobile-power-unit-recall-electrical-issues-may-cause.
Source Summary by GovInfoNow · govinfonow.com/recall/52635-thoratec-heartmate-mobile-power-unit-recall-electrical-issues-may-cause · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1570-2025
Cite this page
“Thoratec HeartMate Mobile Power Unit Recall: Electrical Issues May Cause Unintended.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52635-thoratec-heartmate-mobile-power-unit-recall-electrical-issues-may-cause. Based on FDA recall #Z-1570-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1570-2025%22&limit=1).
Why it’s dangerous
The Mobile Power Unit may have an electrical component that causes it to shut down unexpectedly or restart without warning. This can trigger yellow wrench or no external power alarms. If the unit loses power, the system can support the pump for up to 15 minutes, but if not switched to rechargeable batteries, the pump may lose power.
Who’s affected
Patients using HeartMate 3 or II Left Ventricular Assist Systems with the recalled Mobile Power Units are most at risk. The recall affects units distributed between April 2024 and February 2025.
How to tell if you have this one
Check the serial number on the Mobile Power Unit. Affected units have serial numbers from 20226263 to 20307999. These units were distributed between April 2024 and February 2025 and are used with HeartMate 3 or II Left Ventricular Assist Systems.
- Brand
Thoratec- Category
Medical device
What to do — step by step
Check Serial Number
Look for the serial number on the Mobile Power Unit to confirm if it's affected (20226263 to 20307999).
Ensure Power Source
If the unit loses power, the system can run for up to 15 minutes before stopping. Switch to rechargeable batteries if the unit is not powered by an external source.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 38 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1570-2025 (March 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1570-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.