Medical device manufacturer, Boston Scientific, has issued a field safety notice concerning Imager II™ Angiographic Catheter (Peripheral Intervention).
Boston Scientific found that, during shipping, some units in the 5-pack box may experience a physical interaction between the carton and the area on the pouch where the hub is located. This interaction was found to cause pinholes in the sterile barrier pouch of affected products. The investigation found that these pinholes are not likely to be detected by visual inspection. 13 complaints have been received from Imager pouch damage issues and no adverse health consequence is reasonably expected to occur from these pinholes.
According to the local supplier, the affected products were distributed to Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.