Voluntary recall of specific lots of Pulsar-18, Peripheral Self-expanding Nitinol Stent System

BIOTRONIK AG (‘Biotronik’) would like to inform healthcare professionals of a voluntary recall of selected lots of Pulsar-18, Peripheral Self-expanding Nitinol Stent System of stent length 200mm. Biotronik is initiating this recall due to a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent. Healthcare professionals are advised to discontinue any further use of the affected lots and size, and return all affected devices to Biotronik. Please refer to the letter for details.