Worldwide distribution: USA-AL, CA, FL, IL, MI, MS, NJ, NY, NC, PA, RI, SC, TN, VA, WI, and CANADA, JAPAN, GREAT BRITAIN, NETHERLANDS.
Product Description
Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620 (DT/6-4/5/40, 16-462), Made in Ireland, Ballybrit Business Park, Galway, Ireland || Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
“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.”