—#85902

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.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K980453
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Environmental control

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-10-06
Posted by FDA: 2009-11-20
Terminated: 2011-12-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85902. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.