“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.
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
HeartWare HVAD Controllers and Heartware 1435 DC AdaptersHeartWare HVAD ControllersSerial Numbers below CON3000000Heartware 1435 DC AdaptersAll Serial NumbersARTG Number: 291465
HeartWare HVAD Controller AC Adapter and HeartWare HVAD BatteryController AC Adapter Product Code: 1430XXSerial Numbers: CAC000001 to CAC005796 HVAD BatteryProduct Code: 1650XX and A00035 Serial Numbers: BAT000001 to BAT199999ARTG Number: 181875