“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.”
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제품 설명
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.
Medical Device Safety Alert: Boston Scientific 4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device, and 4mm x 15mm Flextome cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device