Guidant 's Ancure
This article was originally published in The Gray Sheet
Executive Summary
Abdominal aortic anuerysm endovascular graft is recalled from existing hospital inventories and production halted by the company due to deficiencies in regulatory processes associated with deployment of the device and communications with the FDA, company reports March 16. The recall leaves Medtronic's AneuRx as the only AAA stent graft currently available on the U.S. market. Both firms have encountered problems in the past related to deployment of AAA devices. In November 1999, Guidant conducted a Class II recall of 287 Ancure units after a failure in the manufactuing process caused problems in the deployment of the product's attachment system