“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.”
Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon Visera Elite, Light Source Xenon Exera III, High Flow Co2 Insufflator, Scopeguide Unit & Video System Center (components or parts of endoscopes)Model Numbers: OTV-S190, CV-190, 3DV-190, CLV-S190, CLV-190, UHI-4, UPD-3 & CV-170ARTG Numbers: 120819, 120820, 194240, 211802, 219880 & 216644
PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)Catalogue Numbers: 0620040610, 0620040611, 0620040600Multiple Lot Numbers affectedARTG Number: 139712
Conmed GS2000 - 50L Abdominal Insufflator(provides CO2 gas distension of surgical cavities via an endoscope, for diagnostic and/or operative endoscopy)Affected Serial Numbers: 90869KZD and 91114CADARTG Number: 233786