Thoratec Corp. - HeartMate II Left Ventricular Assist System - Class 1 Recall

HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate IITM Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate IITM LVAS Implant Kit, US REF 106015 3. HeartMate IITM LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II¿ LVAS Implant Kit, OUS REF 102139 2. HeartMate II¿ LVAS Implant Kit, US REF 1355 3. HeartMate II¿ LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II¿ LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II¿ LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II¿ LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II¿ LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II¿ LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II¿ LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II¿ LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II" Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventr...
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts