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U.S. Department of Health and Human Services

Class 2 Device Recall Guider Softip XF;

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  Class 2 Device Recall Guider Softip XF; see related information
Date Initiated by Firm October 05, 2016
Date Posted November 02, 2016
Recall Status1 Terminated 3 on March 23, 2017
Recall Number Z-0342-2017
Recall Event ID 75447
510(K)Number K010853  K980453  
Product Classification Catheter, percutaneous - Product Code DQY
Product Guider Softip XF;
GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 .

Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices into the neurovascular system.
Code Information Lot 18786335, 18790229, 18790450. Expiration 12/31/2018. Lot 18851082. Expiration 1/31/2019.
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 2		 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 and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
510(K)s with Product Code = DQY and Original Applicant = BOSTON SCIENTIFIC, TARGET
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