Z-0107-2010

Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed...

Name: Z-0107-2010 Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed...
Creator: Boston Scientific Corporation
Published: 2009-10-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-10-06 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed by Boston Scientific Corporation, Fremont, CA. The... on 2009-10-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0107-2010
Status: Terminated
Initiated: 2009-10-06
Posted: 2009-11-20
Terminated: 2011-12-19
Recalling firm: Boston Scientific Corporation
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.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Product code DQY

K980453Class IISchneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc. / cleared 1998-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)