Thoratec LLC: 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.

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.

Details from the source

Reason for recall: 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. 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, NET Quantity: 1661 Lot/code info: UDI-DI: 05415067038234. MPUs distributed between April 2024 and February 2025. Serial Numbers: 20226263, 20226264, 20226265, 20226266, 20226267, 20226268, 20226269, 20226270, 20226271, 20226272, 20226273, 20226274, 20226275, 20226276, 20226277, 20226278, 20226279, 20226280, 20226281, 20226282, 20226283, 20226284, 20226285, 20226286, 20226287, 20226288, 20226289, 20226290, 20226291, 20226292, 20240622, 20240623, 20240624, 20240625, 20240626, 20240627, 20240628, 20240629, 20240630, 20240631, 20240632, 20240633, 20240634, 20240635, 20240636, 20240637, 20240638, 20240639, 20240640, 20240641, 20240642, 20240643, 20240644, 20240645, 20240646, 20240647, 20240648, 20240649, 20240650, 20240651, 20240652, 20240653, 20240654, 20240655, 20240656, 20240657, 20240658, 20240659, 20240660, 20240661, 20240662, 20240663, 20240664, 20240665, 20240666, 20240667, 20240668, 20240669, 20240670, 20240671, 20240672, 20240673, 20240674, 20240675, 20240676, 20240677, 20240678, 20240679, 20240680, 20240681, 20240682, 20240683, 20240684, 20240685, 20240686, 20240687, 20240688, 20240689, 20240690, 20240691, 20254123, 20254124, 20254125, 20254126, 20254127, 20254128, 20254129, 20254130, 20254131, 20254132, 20254133, 20254134, 20254135, 20254136, 20254137, 20254138, 20254139, 20254140, 20254141, 20254142, 20254143, 20254144, 20254145, 20254146, 20254147, 20254148, 20254149, 20254150, 20254151, 20254152, 20254153, 20254154, 20254155, 20254156, 20254157, 20254158, 20254159, 20254160, 20254161, 20254162, 20254

UPC codes

05415067038234

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.