Distributed in Germany, Great Britain, and the Netherlands.
Descripción del producto
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: || Material number: M004EPM96200, Catalog Number: EPM9620: || Material number: M004EPM9620K20, Catalog Number: EPM9620K2; || Material number : M004EPM9620N40; Catalog number: EPM9620N4. || The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation || The product is not approved for use/sale in the US.
“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.”