Boston Scientific is recalling implanted drug-infusion devices after the FDA issued a warning regarding Boston Scientifics' manufacturing quality control standards. These ports are implanted under the skin and deliver drugs, such as chemotherapy, through a catheter that is attached to a vein. The company has advised doctors to consider surgery for patients to have the recalled port removed. The FDA has received several reports of these devices causing leakage or breakage, which prompted a detailed investigation into Boston Scientifics' manufacturing and regulatory processes. Boston Scientific has issued a voluntary product recall of both valved and nonvalved ports including the Vaxcel Low Profile Infusion Port.
Last year, Boston Scientific announced three product recalls for similar manufacturing problems with their popular cardiac stents. Boston Scientific is a developer and manufacturer of innovative medical products such as catheters, valved and nonvalved implantable ports, stents, and other devices.
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Boston Scientific In the News
Jul-11-06: The FDA released an updated statement supporting Boston Scientific and Guidant's recommendation that physicians should conduct follow-up exams of patients. [FDA]Jan-27-06: The FDA issued a warning letter to Boston Scientific regarding serious problems in the manufacturing processes of their medical devices. The FDA may take additional regulatory action and this may affect the future approval of new medical products. [INDIANAPOLIS STAR]
Jun-27-05: FDA posts press release of the Boston Scientific worldwide recall of Hemashield ® VANTAGE™ Vascular Grafts. [FDA]
Jun-23-05: Doctors feel the responsibility of informing patients of possible defects should be up to the manufacturers. [BOSTON GLOBE]
June-01-05: Numerous patients may need surgery to remove defective drug infusion devices after the FDA issued a warning to Boston Scientific leading to a recall. [BOSTON GLOBE]
May-31-05: Boston Scientific recalls drug-injection devices and recognizes potential charges and fines of up to $2 million. [DOW JONES NEWSWIRES]
