Boroumand.com - Boston Scientific

Boston Scientific Stent Systems

Will they save you or kill you?

{The research and related story is in the process of being written and will be published when complete.}

Contributed to Boroumand by A.R., San Rafael, California, 2006

Documents and Research Sources

Products Overview and Performance

The US Food and Drug Administration (FDA)

FDA MAUDE (Manufacturer and User Faculty Device Experience) - A database of adverse events involving medical devices by manufacturer.

Advanced Search - Utilize this page to access details on Boston Scientific (Manufacturer), Taxus Express (Brand name), Event Type (e.g., Death, Injury, Malfunction, Other). For the 12 months prior to 6/18/2004 and as of 5/8/2006, there were ...

95 Death Events reported,

279 Malfunction Events reported, and

288 Injury Events reported.

FDA Warning Letters

	Jan 25, 2006 - FDA Warning Letter To James Tobin - CEO and Peter Nicholas - Chairman (Re: CGMP-Med Device Reporting/Misbranded) [PDF File]
	Aug 01, 2005 - FDA Warning Letter To James Tobin - CEO (Re: Quality System Regulation - Adulterated) [PDF File]
	Aug 10, 2005 - FDA Warning Letter To James Tobin - CEO (Re: Current Good Mfg Practice Regulation Adulterated) [PDF File]
	May 18, 2005 - FDA Warning Letter To James Tobin - CEO (Re: Current Good Mfg Practice Regulation Adulterated) [PDF File]
	Aug 22, 2003 - FDA Warning Letter To Matthew Jenusaitis - General Manager (Re: CDRH-Sponsor Obligations) [PDF File]

FDA Inspection Recent Reports (Search Page)

	Observations of Boston Scientific Taxus Manufacturing @ Quincy, MA plant (3/2005-5/2005) (PDF File)
	Observations of Boston Scientific Taxus Manufacturing @ Maple Grove, MN plant (7/2005-8/2005) (PDF File)
	Observations of Boston Scientific Manufacturing and Quality Control @ Spencer, IN (8/2005-9/2005) (PDF File)

FDA Recall Database Search Page - Utilize this page to access all class I, II, III recalls by manufacturer (e.g., Boston Scientific). As for 5/9/2006 ...

219 recalls have been made by Boston Scientific

Department of Justice's Civil Division Consumer Litigation Group - Responsible for criminal and civil litigation and related matters arising under a variety of federal statutes administered by its client agencies that protect public health and safety.

The June 24, 2005 press release by the FBI and the DOJ as relate to ongoing investigation concerning Boston Scientifics' 1998 distribution and subsequent recall of one of its coronary stent delivery systems (Boston Scientific v. DOJ and FBI).