“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.”
Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract)Catalogue Numbers: 250-227, 250-228 and 250-229 Material Numbers: M0062502270, M0062502280 and M0062502290Multiple Lot Numbers affectedARTG Number: 126446