Cordis S.M.A.R.T. Flex Vascular Stent System 의 리콜

Recall

RC-2017-RN-00259-1

Class I

2017-02-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00259-1

Based on complaints, cordis has detected a higher frequency of users reporting difficulty with stent deployment of s.M.A.R.T. flex vascularstent system sizes 5x200mm and 6x200mm, compared to other sizes. inherently, longer stents have higher deployment forces, and the s.M.A.R.T.® flex vascular stent system 5x200mm and 6x200mm sizes have higher deployment forces than larger stent diameter sizes of the same length based on differences in the as-cut stent pattern. the most reported deployment difficulty is the inability to deploy the stent resulting in an intra-procedural delay while a replacement device is prepped. however, partial stent deployment may cause ischemia, or internal bleeding, which would require further intervention.

Cordis is requesting customers to check their inventory immediately and quarantine affected stock. Customers are further advised to contact their local sales representative for the return of the affected stock for a product replacement or credit. (Please note that replacements of the same sizes are not currently available.)