Reference 01647/05

Guidant recalls the HEARTSTRING II Aortic Cutters, which are part of the HEARTSTRING II Proximal Seal Systems (model number HSK-2038 and HSK-2043). Due to a sharpness error of the products, the aorta might be cut incompletely or no cut is done by the instruments. The firm concluded, that this could possibly result in an embolic event for the patient. No deaths nor injuries from embolic events have been reported with the usage of the devices. Additionally, the firm warns against the usage of the products upon altered tissue, because this may cause the aortic plug not to be captured by the device and result in the introduction of emboli into the aorta.

Guidant recalls the HEARTSTRING II Aortic Cutters , Download_VeroeffentlichtAm_EN 2005.08.09 PDF, 101KB,