Lifestent Vascular Stent System (200 mm stent length) 의 리콜

Recall

RC-2013-RN-01038-1

Class I

2013-10-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01038-1

After successful introduction of an optimised delivery system design, the device manufacturer angiomed has determined that the optimised lifestent solo vascular stent systems have a significantly lower incidence rate of partial stent deployment associated with their use compared to the original lifestent vascular stent system. the manufacturer, angiomed, has determined that due to the number of lifestent vascular stent system original design devices still available in consignment and customer inventory positions, and the improved performance of the lifestent solo vascular stent system optimized design, a recall action related to the original design product is warranted. this measure will provide customers and patients the lifestent solo optimized stent delivery system performance.

Customers are requested to inspect their stock and quarantine any product from the affected lots. Bard will arrange for the return and replacement of affected stock. No medical or surgical interventions and no monitoring measures are required for LifeStent Vascular Stents which have already been implanted, as the reported partial stent deployments occurred during the release of the stent from the delivery system.