Fetch 2 Aspiration Catheter (used for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature)
모델명 / 제조번호(시리얼번호)
Fetch 2 Aspiration Catheter (used for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature)Material Numbers (UPN): 109400-002, 109400-003, 109400-004 AND 109400-005Multiple batch numbers (see attached)Batch expiration date range: March 2016 to June 2017ARTG number: 181630
“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.”