Medtronic updates Abre stent instructions after rare partial deployment

Medtronic is recalling the Abre Venous Self-Expanding Stent System to tell customers that its Instructions For Use have been updated, the company said in a recall notice published Oct. 26. The update adds a validated manual deployment workaround, a set of steps for completing the placement of the stent by hand, for the rare event that a stent only partly deploys.¹

The company said the new steps appear in the notification letter sent to customers, and that the Abre Instructions For Use will be revised to reflect the same standardized approach pending regulatory approvals. Medtronic said the method should be followed only if a partial stent deployment occurs.¹

"Medtronic is taking this action to reduce the severity of potential patient harms," the notice says. The company said the steps are intended to minimize the risk of serious adverse health consequences in the rare event of partial stent deployment.¹

No product retrievals or disposals are requested as part of the instructions update, Medtronic said. The notice does not describe how often partial deployment has occurred, how many devices or customers are affected, or what specific harms the workaround is meant to prevent.¹