Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Recall
MedSun: Newsletter #72, May 2012

FDA MedWatch Safety Alert

Recall due to detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow graft. Additionally, the metal end of the bend relief may be sharp and cause erosion and cutting of the outflow graft. This product may cause serious adverse health consequences, including death.

Additional Information:

FDA MedWatch Safety Alert. Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Recall. April 4, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298710.htm


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