FDA MedWatch - Boston Scientific Devices Stolen - Risk of Infection

AUDIENCE: Risk Manager, Gastroenterology, Urology

ISSUE: Boston Scientific Corporation is alerting the public about a stolen shipment of Endoscopy and Urology/Women's Health medical devices. These devices were stolen while en route to Boston Scientifics' sterilization facility sometime between April 8, 2011 and April 11, 2011.

The labels on these devices state that they are “Sterile”; however, they were stolen prior to being sterilized and are non-sterile. Use of these non-sterile devices may lead to infection.

BACKGROUND: Only the specific UPNs and Batches identified in the press release are affected. Unusually low pricing may be an indication that the product has been stolen.

RECOMMENDATION: If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, do not use the devices and contact Boston Scientific.

It is recommended that health care professionals monitor and treat patients for adverse events, such as post-operative infection, if they suspect or know that the stolen non-sterile devices have been used.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

•Complete and submit the report Online

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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