“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.
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Product Description
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems || Model Numbers: || ETBF2516C145E || ETBF2516C166E || ETBF2316C145E || ETBF2313C145E || ETBF2513C166E || ETBF2313C166E || ETBF2316C166E || ETBF2313C124E || ETBF2513C145E || ETBF2516C124E || ETBF2316C124E || ETBF2513C124E. || Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient's vasculature.
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems(indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms)Multiple Product and Serial NumbersARTG Numbers: 158456, 197539