Class 3 Device Recall Boston Scientific Guider Softip XF Guiding Catheter

• Date Initiated by Firm: July 11, 2007
• Date Posted: November 24, 2007
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-0259-2008
• Recall Event ID: 38445
• 510(K)Number: K980453
• Product Classification: Guiding Catheter - Product Code DQY
• Product: Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number : 10042, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
• Code Information: LOT 9311885, Catalogue #10042, Material #H965100420, Expires 10-JAN-2010
• Recalling Firm/ Manufacturer: Boston Scientific Target; 47900 Bayside Pkwy; Fremont CA 94538-6515
• For Additional Information Contact: 510-440-7700
• Manufacturer Reason for Recall: Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter)
• FDA Determined Cause: Labeling mix-ups
• Action: Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.
• Quantity in Commerce: 47 units
• Distribution: Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
• 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 = DQY