Class 2 Device Recall Boston Scientific mach 1 Guide Catheter

• Date Initiated by Firm: September 11, 2007
• Date Posted: October 27, 2007
• Recall Status: Terminated on February 24, 2008
• Recall Number: Z-0103-2008
• Recall Event ID: 44901
• Product Classification: Guide Catheter - Product Code DQY
• Product: Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550
• Code Information: Lot/Batch # 572191
• Recalling Firm/ Manufacturer: Boston Scientific; 1 Scimed Pl; Maple Grove MN 55311-1565
• Manufacturer Reason for Recall: Missing holes: Catheters are missing the catheter's side holes.
• FDA Determined Cause: Process control
• Action: A voice mail was left to affected members of the domestic sales force on September 11, 2007 and an interoffice memo with the recall implementation instructions was also sent to the Sales Force. An Urgent Voluntary Medical Device Recall letter dated September 11, 2007, was sent to affected consignees describing the problem and products affected. The letter included the customer steps for recall, a Reply Verification Tracking Form and a return shipping label.
• Quantity in Commerce: 6
• Distribution: Worldwide: NY, PA, and Japan
• 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.