The company is recalling the devices over reports of deployment difficulty with the devices in the 2 particular sizes.
The most commonly reported deployment issue is the inability to deploy the stent, which can result in intra-procedural delays while a replacement device is prepped, Cordis said.
Cordis warned that partial stent deployment could cause ischemia which would require further intervention.
A total of 3 patient injuries have been reported globally associated with deployment issues, Cordis said.
The recall affects all unexpired lots of S.M.A.R.T. flex vascular stent systems in sizes 5x200mm and 6x200mm with catalog numbers SF05200MV, SF05200SV, SF06200MV, and SF06200SV. The company added that the recall does not affect any stents that have already been deployed.
The company began notifying customers of the issues on Feb. 16, according to the field safety notice, advising customers to return the selected lots of the devices to Cordis.
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