Class 2 Device Recall Neuroform 3 Microdelivery Stent System

• Date Initiated by Firm: May 08, 2009
• Date Posted: September 09, 2009
• Recall Status: Terminated on October 21, 2009
• Recall Number: Z-2052-2009
• Recall Event ID: 52668
• Product Classification: Intracranial Neurovascular Stent - Product Code NJE
• Product: Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
• Code Information: Batch numbers 8048028 and 8048029.
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 47900 Bayside Pkwy; Fremont CA 94538-6515
• For Additional Information Contact: 508-652-5594
• Manufacturer Reason for Recall: Mislabeling-- Product was placed in a carton, which has printed on it the name of another product. A correct product label was placed on the carton.
• FDA Determined Cause: Employee error
• Action: The firm issued an Urgent Product Field Action Notice to all listed customers, along with a reply verification form, requesting the return of affected products.
• Quantity in Commerce: 8 units
• Distribution: International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.