Class 2 Device Recall Boston Scientific Scimed Express II

• Date Initiated by Firm: July 16, 2003
• Date Posted: August 12, 2003
• Recall Status: Terminated on December 28, 2006
• Recall Number: Z-1123-03
• Recall Event ID: 26881
• PMA Number: P020009
• Product Classification: Stent, Coronary - Product Code MAF
• Product: Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
• Code Information: Lot 5570485
• FEI Number: 3002095335
• Recalling Firm/ Manufacturer: Boston Scientific Scimed; One Scimed Place; Maple Grove MN 55311-1566
• For Additional Information Contact: Patrick Burt; 763-494-1192
• Manufacturer Reason for Recall: There is an Increased potential for broken struts of the stents.
• FDA Determined Cause: Other
• Action: Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
• Quantity in Commerce: 17 stent systems
• Distribution: The products were shipped to consignees located nationwide in the United States.
• 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.

• PMA Database: PMAs with Product Code = MAF