Mosaic Porcine Aortic Bioprosthesis Model 305 and Medtronic Aortic Obturators/Sizers and iOEA Charts Hazard Alert - MosaicPorcine Aortic Bioprosthesis Model 305 All sizes and configurations ie, Standard and Ultra Recall - Medtronic Aortic Obturators/Sizers and iOEA -indexed Effective Orifice Area Charts
모델명 / 제조번호(시리얼번호)
Mosaic Porcine Aortic Bioprosthesis Model 305 and Medtronic Aortic Obturators/Sizers and iOEA Charts Hazard Alert - MosaicPorcine Aortic Bioprosthesis Model 305 All sizes and configurations ie, Standard and UltraARTG 145761Recall - Medtronic Aortic Obturators/Sizers and iOEA -indexed Effective Orifice Area Charts Model Numbers: 7305, 7305OD, 7305UXARTG 98977
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.