Stolen Medical Devices Prompt Warning

The U.S. Food and Drug Administration (FDA) just issued an urgent release over a potential infection risk. The risk was announced in an alert from Boston Scientific Corporation in which it announced a stolen shipment of <"">Endoscopy and Urology/Women’s Health medical devices. The devices were stolen while en route to Boston Scientific’s 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 nonsterile. Use of these non-sterile devices may lead to infection.

Healthcare professionals are advised to:

• Check inventory for affected product.

• Segregate the product.
• Monitor all incoming shipments for affected product.

Boston Scientific also recommends that health care professionals monitor and treat patients for adverse events, such as post-operative infection, if they suspect or know that the nonsterile devices have been used. A complete list of these devices can be accessed on the FDA website at:

Only the specific UPNs and batches identified in this breakdown, which also includes descriptions and catalog numbers, are affected. If any of these identified devices are in current inventory or if future delivery contains these batches of devices, do not use the devices and contact Boston Scientific at 1.866.868.4004. Boston Scientific can also be reached at for information on device labeling, device photos, and other additional information concerning this issue.

Distributors are advised to notify their customers.

Boston Scientific notes that diligence should be paid to suspicious transactions relating to the involved devices. For example, unusually low pricing could indicate that the product has been stolen.

Anyone who has information regarding this incident or has received suspicious or unsolicited offers for the devices identified above, after the date of the theft, is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1.800.551.3989 or by visiting the OCI Web Site.

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.