Class 2 Device Recall Boston Scientific Scimed

• Date Initiated by Firm: March 17, 2003
• Date Posted: April 22, 2003
• Recall Status: Terminated on July 02, 2004
• Recall Number: Z-0778-03
• Recall Event ID: 25947
• PMA Number: P970061
• Product Classification: Stent, Coronary - Product Code MAF
• Product: Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401
• Code Information: Lot number 5350197
• Recalling Firm/ Manufacturer: Boston Scientific Scimed; One Scimed Place; Maple Grove MN 55311-1566
• Manufacturer Reason for Recall: A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
• FDA Determined Cause: Other
• Action: Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them.
• Quantity in Commerce: 7 Stent Systems
• Distribution: 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