“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.”
4.0mm x15mm Small Peripheral Cutting Balloon (Monorail & Over-the-Wire ) Microsurgical Dilatation Device (used for Percutaneous Transluminal Angioplasty of obstructive lesions in peripheral vessels) and 4.00mm x15mm Flextome Cutting Balloon (Monorail & Over-the-Wire) Microsurgical Dilatation Device (used in patients with coronary vessel disease) Multiple catalogue numbers and lot numbers Expiration Date Range: 16-Nov-2015 to 03-Jun-2016ARTG Numbers: 168036 and 169861
Nationwide plus Argentina Austria Belgium Brunei Canada Chile China Colombia Czech Republic Denmark Finland France Germany Great Britain Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. Singapore South Africa Spain Sweden Switzerland & Turkey
Product Description
The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.