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U.S. Department of Health and Human Services

Class 2 Device Recall Guider XF Softip Guide Catheter

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 Class 2 Recall
Guider XF Softip Guide Catheter
see related information
Date Posted November 20, 2009
Recall Status1 Terminated on December 19, 2011
Recall Number Z-0107-2010
Recall Event ID 53579
Premarket Notification
510(K) Number
K980453 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed by Boston Scientific Corporation, Fremont, CA. The device is intended to facilitate placement of interventional devices into the neurovascular system.
Code Information UPN/Model numbers: H965100420/10042, H965100430/10043, H965100440/10044, H965100460/10046, H965100470/10047, H965100480/10048, H965100500/10050, H965100510/10051, H965100520/10052, M003100620/10062, M003100630/10063, M003100640/10064, M003101420/10142, M003101430/10143, M003101440/10144, M003101460/10146, M003101470/10147, M003101480/10148, M003101500/10150, M003101510/10151, M003101520/10152, M003101620/10162, M003101630/10163 and M003101640/10164.
Recalling Firm/
Manufacturer
Boston Scientific Corporation
47900 Bayside Pkwy
Fremont, California 94538-6515
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Environmental Control
Action The firm initiated its 'Safety Alert' on October 6, 2009. A notification letter was sent to each customer reminding them to follow storage and handling instructions. The firm has not ceased distribution. Direct questions about this notification to the Boston Scientific Corporation at 1-510-624-1734.
Quantity in Commerce 94,296 units
Distribution Worldwide Distribution -- United States, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, UAE, Uruguay, Venezuela, Vietnam and Yemen.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
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