The FDA, law enforcement and Boston Scientific are working together to recover a shipment of endoscopy and urology/women's health medical devices stolen en route to the company's sterilization facility sometime between April 8 and April 11.
In a notice, Boston Scientific says that even though the labels on these devices might say they're sterile, they were stolen before the products were actually sterilized. Use of these non-sterile devices may lead to infection. The company advises that healthcare professionals monitor and treat patients for adverse events, including post-operative infection.
Only the specific universal product numbers and batches that Boston Scientific identifies in its notice are affected. The alerts says unusually low pricing may indicate the product has been stolen.
Affected devices include certain lots of products in the Resolution line, including the Resolution II, a clipping device used for placement in the gastro-intestinal tract. It also includes certain lots of the Flexiva and AccuMax devices, both of which are fiberoptic laser energy delivery devices, as well as a the Advantage system implantable mesh sling and a single lot of the Pinnacle pelvic repair kit.
- see the Boston Scientific notice (includes UPNs and lot numbers)