FDA-Device2025-04-23Class I
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.
Thoratec LLC
Hazard
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.
Sold states
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.
Affected count
1661
Manufactured in
6035 Stoneridge Dr, Pleasanton, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1570-2025Don't want to check this manually?
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