Recall Z-1570-2025— Thoratec LLC
Class I · Ongoing
Class I FDA medical device recall by Thoratec LLC, initiated 2025-03-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Thoratec LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-03-13
- Firm location
- Pleasanton, CA, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.