Vascutek Initiates Voluntary Recall of Anaconda Bifurcate Body Stent Graft System

October 21, 2013—Vascutek Ltd. (Inchinnan, United Kingdom) announced that it issued a Field Safety Notice initiating a voluntary recall of the Anaconda bifurcate body stent graft system, which is used to treat abdominal aortic aneurysms. The company stated that an issue in the Anaconda system's release wire in the delivery system is currently being investigated. The issue was discovered through Vascutek's postmarket surveillance system. More than 17,000 Anaconda stent grafts have been implanted since the system was launched in 2005, noted the company.

Vascutek's President and Chief Executive Officer, Paul Holbrook, advised in the company's press release that the failure mode is specifically associated with the delivery system used to implant the stent graft, and that patients who have previously benefitted from an Anaconda stent graft are not affected by this voluntary recall and should not be concerned.

Mr. Holbrook commented, “Vascutek has recently received three separate reports of failures in a release wire in the Anaconda delivery system. We are fully committed to the highest standards of patient safety and product quality, and have taken the decision, as a precautionary measure, to voluntarily recall all Anaconda bifurcate body stent graft systems. I am confident that Vascutek engineers will find the root cause of this issue and that the Anaconda system will be available as quickly as possible.”

Mr. Holbrook continued, “I would like to reassure customers that it is our intention to make the Anaconda system available to clinicians and their patients as quickly as possible. We will not do this until we are satisfied that the component issue, which has been identified, has been resolved. We will then work with relevant regulatory authorities so that patients who need this specialized and effective device have access to it as quickly as is practical.”