Class 3 Device Recall Boston ScientificRenegade HiFlo Microcatheter Kit

• Date Initiated by Firm: September 10, 2007
• Date Posted: October 31, 2007
• Recall Status: Terminated on December 20, 2007
• Recall Number: Z-0109-2008
• Recall Event ID: 44939
• 510(K)Number: K000177
• Product Classification: Microcatheter Kit - Product Code KRA
• Product: Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
• Code Information: Lot Numbers: 9218692; 9218628; 9218451
• FEI Number: 3005099803
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: 508-650-8798
• Manufacturer Reason for Recall: Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
• FDA Determined Cause: Packaging process control
• Action: Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the use of the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form
• Quantity in Commerce: 153
• Distribution: Nationwide
• 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.

• 510(K) Database: 510(K)s with Product Code = KRA