Reported Apr 23, 2025 · Ongoing
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with…
Thoratec LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thoratec LLC · 6035 Stoneridge Dr · Pleasanton, CA · 94588-3270
Is this the product you have?
- HeartMate Mobile Power UnitREF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System
- Lot codes and dates
- UDI-DI05415067038234. MPUs distributed between April 2024 and February 2025
- Serial Numbers
1,661 of 1,661 codes
202262632022626420226265202262662022626720226268202262692022627020226271202262722022627320226274202262752022627620226277202262782022627920226280202262812022628220226283202262842022628520226286202262872022628820226289202262902022629120226292202406222024062320240624202406252024062620240627202406282024062920240630202406312024063220240633202406342024063520240636202406372024063820240639202406402024064120240642202406432024064420240645202406462024064720240648202406492024065020240651
- Amount recalled
- 1661
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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