HeartWare Ventricular Assist SystemController/Controller KitsModel Numbers (may contain various suffixes): 1400, 1401, 1403, 1407 and 1420DC AdapterModel Numbers (may contain various suffixes): 1435 and 1440AC AdapterModel Numbers (may contain various suffixes): 1425 and 1430Battery PackModel Numbers (may contain various suffixes): 1650All Serial Numbers of the above modelsARTG Number: 181875
“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.