“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
Encore 26 Advantage Kit & Encore 26 Advantage Kit, 5 pack (Used to perform general intravascular procedures)Encore 26 Advantage KitMaterial Number: H74904527011Catalogue Number: 04527-01Encore 26 Advantage Kit (5 pack)Material Number: H74904527052Catalogue Number: 04527-05Multiple Lot NumbersExpiration dates between 13 August 2014 & 30 September 2014Manufactured between 3 August 2012 & 18 September 2012ARTG Number: 159833