BfArM - Federal Institute for Drugs and Medical Devices

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Product group Non-active implants
Reference 01464/08

Boston Sientific recalls Epic™ Over-The-Wire Self-Expanding Nitinol Vascular Stents with Delivery Systems due to reported cases of difficulty experienced in removing the stent delivery system which could result in trauma to the tissue of the targeted site, including perforation or dissection.

Recall Epic™, Boston Sientific , Download_VeroeffentlichtAm_EN PDF, 96KB, File does not meet accessibility standards