Class 2 Device Recall Guider Softip XF;

• Date Initiated by Firm: October 05, 2016
• Date Posted: November 02, 2016
• Recall Status: Terminated on March 23, 2017
• Recall Number: Z-0338-2017
• Recall Event ID: 75447
• 510(K)Number: K010853 K980453
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
• Code Information: Lot s: 18725976, 18726252, 18726453. Expiration 12/31/18. Lot: 18771999, Expiration 01/31/2019. Lot 19022528, Expiration 03/31/2019.
• Recalling Firm/ Manufacturer: Stryker Neurovascular; 47900 Bayside Pkwy; Fremont CA 94538-6515
• For Additional Information Contact: Geraldine Ahern; 510-413-2106
• Manufacturer Reason for Recall: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
• FDA Determined Cause: Employee error
• Action: Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated October 5, 2016, to all affected customers by Federal Express. Letters advised of the reason for recall and models and devices affected and requested that all affected devices in inventory be returned to Stryker. Customers were advised to circulate the Field Safety Notice internally to all interested/affected parties and to complete the attached customer response form and return the form to their nominated Stryker Representative or to NVFieldActions@stryker.com. For questions regarding this recall call 510-413-2106.
• Quantity in Commerce: 1478 devices, all models and lot numbers.
• Distribution: Worldwide Distribution - US including AK, IL, OH and Internationally to: ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CZECH REPUBLIC ECUADOR EGYPT FRANCE GERMANY GREECE HUNGARY INDIA IRAN ISRAEL ITALIA JAPAN MEXICO NETHERLANDS NORWAY PERU PHILIPPINES POLAND RUSSIA SERBIA SINGAPORE SLOVAKIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND THAILAND TUNISIA TURKEY UK URUGUAY VIETNAM.
• 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; 510(K)s with Product Code = DQY