Events

Recall of Cordis S.M.A.R.T. Flex Vascular Stent System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Cardinal Health Australia 503 Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00259-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00259-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.)

Device

Cordis S.M.A.R.T. Flex Vascular Stent System
  • Model / Serial
    Cordis S.M.A.R.T. Flex Vascular Stent System Catalogue Numbers: SF05200SV and SF06200SVStent size and catheter length: 5 x 200mm, 80cmGTIN: 20705032066409 and 20705032067024Catalogue Numbers: SF05200MV and SF06200MVStent size and catheter length: 5 x 200mm, 120cmGTIN: 20705032066829 and 20705032066836All unexpired lots (Lot range 34469 through 39974)ARTG Number: 223910
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Cardinal Health Australia 503 Pty Ltd

Manufacturer

Cardinal Health Australia 503 Pty Ltd